System, Test, Automated, Antimicrobial Susceptibility, Short Incubation

FDA product code LON · 285 cleared devices

Class 2 Microbiology

Regulation: 21 CFR 866.1645
Review panel: MI
Implant: No
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1986-08-01 – 2026-04-15

LON 2008-03-05

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-DAPTOMYCIN (0.0313-16 UG/ML) STEPTOCOCCUS ID/AST OR AST ONLY PHOENIX PANELS

Applicant Becton, Dickinson & CO

K number K073589

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LON 2008-02-28

VITEK 2 GRAM NEGATIVE PIPERACILLIN/TAZOBACTAM

Applicant bioMerieux, Inc.

K number K080107

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LON 2008-01-23

VITEK 2 GRAM NEGATIVE TRIMETHOPRIM/SULFAMETHOXAZOLE

Applicant bioMerieux, Inc.

K number K073406

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LON 2008-01-14

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-PIPERACILLIN (GN) -128 UG/ML

Applicant Becton, Dickinson & CO

K number K073433

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LON 2007-12-10

VITEK 2 GRAM NEGATIVE PIPERACILLIN

Applicant bioMerieux, Inc.

K number K073083

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LON 2007-11-16

VITEK 2 GRAM POSITIVE TIGECYCLINE

Applicant bioMerieux, Inc.

K number K072695

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LON 2007-10-15

VITEK 2 GRAM POSITIVE VANCOMYCIN

Applicant bioMerieux, Inc.

K number K072668

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LON 2007-09-24

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-MINOCYCLINE (GP) 1-32 UG/ML

Applicant Becton, Dickinson & CO

K number K070809

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LON 2007-09-12

VITEK 2 GRAM NEGATIVE LEVOFLOXACIN

Applicant bioMerieux, Inc.

K number K072038

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LON 2007-08-20

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM, AMPICILLIN-SULBACTAM (GN) 1/0.5-32/16 UG/ML

Applicant Becton, Dickinson & CO

K number K071623

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LON 2007-08-20

MICROSCAN SYNERGIES PLUS GRAM POSITIVE MIC/COMBO PANELS NEW ANTIMICROBIAL-GENTAMICIN SYNERGY SCREEN

Applicant Dade Behring, Inc.

K number K071317

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LON 2007-07-18

DADE BEHRING LABPRO ALERT SOFTWARE SYSTEM

Applicant Dade Behring, Inc.

K number K070346

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LON 2007-06-26

MICROSCAN SYNERGIES PLUS GRAM POSITIVE MIC/COMBO PANELS WITH TETRACYCLINE

Applicant Dade Behring, Inc.

K number K071268

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LON 2007-05-21

SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS

Applicant Dade Behring, Inc.

K number K071076

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LON 2007-05-11

MICROSCAN SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS WITH CLINDAMYCIN

Applicant Dade Behring, Inc.

K number K070860

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LON 2007-03-07

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM MINOCYCLINE (1-32 UG/ML) GRAM NEGATIVE ID/AST OR AST ONLY

Applicant Becton, Dickinson & CO

K number K063486

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LON 2007-02-14

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - AZTREONAM (GN) 0.5-64UG/ML

Applicant Becton, Dickinson & CO

K number K063824

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LON 2007-02-09

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFAZOLIN (GN) 0.5-32UG/ML

Applicant Becton, Dickinson & CO

K number K063811

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LON 2007-02-08

MICROSCAN SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS WITH CHLORAMPHENICOL (4-16 UG/ML)

Applicant Dade Behring, Inc.

K number K063564

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LON 2007-01-29

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFPODOXIME (GN) 0.125-8UG/ML

Applicant Becton, Dickinson & CO

K number K063300

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LON 2007-01-19

VITEK 2 GRAM POSITIVE AMOXICILLIN FOR STREPTOCOCCUS PNEUMONIAE

Applicant bioMerieux, Inc.

K number K063597

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LON 2007-01-11

VITEK 2 GRAM POSITIVE MEROPENEM FOR STREPTOCOCCUS PNEUMONIAE

Applicant bioMerieux, Inc.

K number K063623

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LON 2007-01-11

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-CEFTAZIDIME (GN) 0.5-64 UG/ML

Applicant Becton, Dickinson & CO

K number K063573

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LON 2006-12-21

VITEK 2 GRAM POSITIVE ERYTHROMYCIN FOR STREPTOCOCCUS PNEUMONIAE

Applicant bioMerieux, Inc.

K number K063492

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LON 2006-12-08

MICROSCAN SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANEL WITH SYNERCID (0.12-2UG/ML 5DILUTION BREAKPOINT SEQUENCE

Applicant Dade Behring, Inc.

K number K063366

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LON 2006-12-08

SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS WITH GENTAMICIN (0.06-32MG/ML LONG DILUTION SEQUENCE

Applicant Dade Behring, Inc.

K number K063365

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LON 2006-12-08

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFEPIME (GN) 0.5-64UG/ML

Applicant Becton, Dickinson & CO

K number K063301

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LON 2006-11-21

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - ERTAPENEM (GN) 0.25-32 UG/ML

Applicant Becton, Dickinson & CO

K number K062945

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LON 2006-11-20

MICROSCAN SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS WITH NITROFURANTOIN (2 - 256 UG/ML

Applicant Dade Behring, Inc.

K number K062938

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LON 2006-11-15

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFTRIAXONE (GN) 0.5-64UG/ML

Applicant Becton, Dickinson & CO

K number K062944

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LON 2006-10-24

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEN - TICARCILLIN-CLAVULANATE (GN) 1/2 - 128/2UG/ML

Applicant Becton, Dickinson & CO

K number K062687

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LON 2006-10-20

SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS WITH LINEZOLID

Applicant Dade Behring, Inc.

K number K062705

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LON 2006-10-05

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - TICARCILLIN (GN) 1-128 UG/ML

Applicant Becton, Dickinson & CO

K number K062680

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LON 2006-09-13

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFUROXIME (GN) 1-64 UG/ML

Applicant Becton, Dickinson & CO

K number K062207

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LON 2006-09-08

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - MOXIFLOXACIN (STREP) 0.0625 - 8UG/ML

Applicant Becton, Dickinson & CO

K number K062206

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LON 2006-08-18

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-PIPERACILLIN-TAZOBACTAM (GP) 1/4-128/4 UG/ML

Applicant Becton, Dickinson & CO

K number K061869

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LON 2006-08-10

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-CEFAZOLIN (GN) 0.5-32 UG/ML

Applicant Becton, Dickinson & CO

K number K061867

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LON 2006-07-28

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-AMOXICILLIN-CLAVULANATE(GP) 0.25/0.12 -32/16 UG/ML

Applicant Becton, Dickinson & CO

K number K061673

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LON 2006-07-03

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-AMOXICILLIN-CLAVULANATE (GN) 0.5/0.25-32/16 UG/ML, AMPICILLIN-SULBACTAM (GN) 0.

Applicant Becton, Dickinson & CO

K number K061327

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LON 2006-06-20

VITEK 2 GRAM POSITIVE VRSA SCREEN

Applicant bioMerieux, Inc.

K number K061347

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LON 2006-06-07

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - AMPICILLIN (GN) 0.5-32 UG/ML

Applicant Becton, Dickinson & CO

K number K061355

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LON 2006-05-25

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM FOR USE WITH THE ANTIMICROBIAL AGENT GATIFLOXACIN 0.25-8 UG/ML - GRAM-NEGATIVE

Applicant Becton, Dickinson & CO

K number K060324

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LON 2006-05-11

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM CEPHALOTHIN - GN 1 - 64 UG/ML

Applicant Becton, Dickinson & CO

K number K060558

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LON 2006-04-26

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM -NITROFURANTOIN (GN) 8-512 UG/ML, TRIMETHOPRIM-SULFAMETHOXAZOLE (GN)

Applicant Becton, Dickinson & CO

K number K060447

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LON 2006-04-14

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFOXITIN - 0.5-64 UG/ML

Applicant Becton, Dickinson & CO

K number K060257

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LON 2006-04-12

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFEPIME (GN) , CEFTRIAXONE (GN), CEFOTAXIME (GN), 0.5-64 UG/ML

Applicant Becton, Dickinson & CO

K number K060444

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LON 2006-04-12

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - MOXIFLOXACIN-0.125-8 AND CIPROFLOXACIN-0.25 - 4 UG/ML

Applicant Becton, Dickinson & CO

K number K060217

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LON 2006-03-29

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - VANCOMYCIN-GP DETECTION OF VRSA.

Applicant Becton, Dickinson & CO

K number K060493

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LON 2006-03-23

MICROSCAN SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS WITH VANCOMYCIN (0.25-64 UG/ML)

Applicant Dade Behring, Inc.

K number K060312

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LON 2006-03-17

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - ERYTHROMYCIN-0.0625-8 UG/ML, AND QUINUPRISTIN/DALFOPRISTIN-0.25-4 UG/ML

Applicant Becton, Dickinson & CO

K number K060218

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LON 2006-03-09

BD PHOENIX AUTOMATED MIRCROBIOLOGY SYSTEM TETRACYCLINE-GN 0.5-16 UG/ML AND GP 0.5-16 UG/ML

Applicant Becton, Dickinson & CO

K number K060214

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LON 2006-02-24

MICROSCAN SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS WITH ERYTHROMYCIN (0.12-16 UG/ML)

Applicant Dade Behring, Inc.

K number K053504

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LON 2006-02-03

MICROSCAN SYNERGIES PLUS GRAM POSITIVE MIC/COMBO PANELS - AMPICILLIN

Applicant Dade Behring, Inc.

K number K060088

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LON 2005-12-22

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFOXITIN GP 1-32 G/ML

Applicant Becton, Dickinson & CO

K number K053241

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LON 2005-12-14

VITEK 2 GRAM POSITIVE CEFOXITIN SCREEN

Applicant bioMerieux, Inc.

K number K053097

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LON 2005-12-01

VITEK 2 GRAM POSITIVE TELITHROMYCIN FOR STREPTOCOCCUS PNEUMONIAE

Applicant bioMerieux, Inc.

K number K053186

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LON 2005-11-07

VITEK GRAM POSITIVE SUSCEPTIBILITY DAPTOMYCIN

Applicant bioMerieux, Inc.

K number K052656

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LON 2005-10-26

SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS

Applicant Dade Behring, Inc.

K number K052346

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LON 2005-10-05

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFUROXIME (STREP) 0.125 - 4UG/ML

Applicant Becton, Dickinson & CO

K number K052270

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LON 2005-10-03

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM -CIPROFLOXACIN GN

Applicant Becton, Dickinson & CO

K number K052269

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LON 2005-09-30

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - TOBRAMYCIN (GP) 0.5-16UG/ML

Applicant Becton, Dickinson & CO

K number K052250

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LON 2005-09-29

VITEK 2 GRAM NEGATIVE TIGECYCLINE

Applicant bioMerieux, Inc.

K number K052311

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LON 2005-08-16

VITEK 2 GRAM POSITIVE ERTAPENEM FOR STREPTOCOCCUS PNEUMONIAE

Applicant bioMerieux, Inc.

K number K051849

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LON 2005-08-05

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - DAPTOMYCIN 0.125 - 32 UG/ML

Applicant Becton, Dickinson & CO

K number K051689

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LON 2005-07-27

MICROSCAN SYNERGIES PLUS GRAM POSITIVE MIC/COMBO PANELS - RIFAMPIN

Applicant Dade Behring, Inc.

K number K051478

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LON 2005-07-25

SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS

Applicant Dade Behring, Inc.

K number K051350

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LON 2005-07-14

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - AMOXICILLIN (STREP) 0.0313 - 32 UG/ML

Applicant Becton, Dickinson & CO

K number K051692

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LON 2005-07-12

MICROSCAN SYNERGIES PLUS GRAM POSITIVE MINIMUM INHIBITORY CONCENTRATION/COMBO PANELS - LEVOFLOXACIN

Applicant Dade Behring, Inc.

K number K051311

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LON 2005-07-11

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CLINDAMYCIN (STREP) 0.03125 -4 UG/ML

Applicant Becton, Dickinson & CO

K number K051272

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LON 2005-07-05

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - LINEZOLID (STREP) 0.25 - 16UG/ML

Applicant Becton, Dickinson & CO

K number K051266

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LON 2005-06-24

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM CEFEPIME (STREP) 0.0625-4UG/ML

Applicant Becton, Dickinson & CO

K number K051204

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LON 2005-06-21

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - GATIFLOXACIN (STREP) 0.0625 -8UG/ML

Applicant Becton, Dickinson & CO

K number K051183

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LON 2005-06-15

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - ERYTHROMYCIN (STREP) 0.0156 - 4UG/ML

Applicant Becton, Dickinson & CO

K number K051109

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LON 2005-06-03

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFTRIAXONE (STREP) 0.0625 - 4UG/ML

Applicant Becton, Dickinson & CO

K number K051138

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LON 2005-05-27

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-MEROPENEM (STREP) 0.03125-2 UG/ML

Applicant Becton, Dickinson & CO

K number K050946

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LON 2005-05-24

BD PHONIX AUTOMATED MICROBIOLOGY SYSTEM - CEFOTAXIME STREP (0.0625-4UG/ML)

Applicant Becton, Dickinson & CO

K number K050982

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LON 2005-05-23

VITEK 2 GRAM POSITIVE TRIMETHOPRIM/SULFAMETHOXAZOLE

Applicant bioMerieux, Inc.

K number K050976

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LON 2005-05-20

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-TRIMETHOPRIM-SULFAMETHOXAZOLE 0.0625/1.2-16/304 UG/ML

Applicant Becton, Dickinson & CO

K number K050865

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LON 2005-05-12

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - TETRACYCLINE (STREP) 0.0625 - 16 UG/ML

Applicant Becton, Dickinson & CO

K number K050881

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LON 2005-05-12

VITEK 2 GRAM POSITIVE MEROPENEM

Applicant bioMerieux, Inc.

K number K050816

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LON 2005-05-12

BD PHOENIXTM AUTOMATED MICROBIOLOGY SYSTEM - PENICILLIN (STREP) 0.156 -32 UG/ML

Applicant Becton, Dickinson & CO

K number K050780

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LON 2005-04-29

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM, LEVOFLOXACIN (STREP) 0.25-16 UG/ML

Applicant Becton, Dickinson & CO

K number K050747

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LON 2005-04-29

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM, VANCOMYCIN (STREP) 0.0625 -32 UG/ML

Applicant Becton, Dickinson & CO

K number K050745

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LON 2005-04-14

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFAZOLIN (GP) 2-32 UG/ML

Applicant Becton, Dickinson & CO

K number K050555

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LON 2005-03-22

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEPHALOTHIN (GP) 0.5-64 UG/ML

Applicant Becton, Dickinson & CO

K number K050400

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LON 2005-03-15

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFOTETAN (GN) 2-64 UG/ML

Applicant Becton, Dickinson & CO

K number K043458

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LON 2005-02-28

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - AMPICILLIN-SULBACTAM (GP) 2-32 UG/ML

Applicant Becton, Dickinson & CO

K number K050089

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LON 2005-02-28

VITEK 2 GRAM POSITIVE DAPTOMYCIN

Applicant bioMerieux, Inc.

K number K050075

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LON 2005-02-18

VITEK 2 GRAM POSITIVE ERTAPENEM

Applicant bioMerieux, Inc.

K number K050076

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LON 2005-02-17

VITEK 2 COMPACT

Applicant bioMerieux, Inc.

K number K050002

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LON 2005-01-21

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM -AMPICILLIN-SULBACTAM (GN) 0.5/0.25-32/16UG/ML

Applicant Becton, Dickinson & CO

K number K043389

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LON 2004-12-30

VITEK GRAM NEGATIVE SUSCEPTIBILITY (GNS) CARD FOR ERTAPENEM

Applicant bioMerieux, Inc.

K number K043230

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LON 2004-12-23

VITEK GRAM NEGATIVE SUSCEPTIBILITY (GNS) CARD FOR MOXIFLOXACIN

Applicant bioMerieux, Inc.

K number K043237

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LON 2004-12-13

VITEK GRAM POSITIVE SUSCEPTIBILITY (GPS) CARD FOR ERTAPENEM

Applicant bioMerieux, Inc.

K number K042963

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LON 2004-12-07

VITEK GRAM POSITIVE SUSCEPTIBILITY (GPS) CARD FOR RIFAMPIN

Applicant bioMerieux, Inc.

K number K042946

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LON 2004-12-02

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-PIPERACILLIN-TAZOBACTAM 0.5/4-128/4 UG/ML

Applicant Becton, Dickinson & CO

K number K042932

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LON 2004-09-14

VITEK 2 GRAM NEGATIVE ERTAPENEM

Applicant bioMerieux, Inc.

K number K041982

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LON 2004-08-12

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-PIPERCILLIN (GN) 0.5-128 UG/ML

Applicant Becton, Dickinson and Co.

K number K041572

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LON 2004-08-03

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFTAZIDIME - GRAM NEGATIVE

Applicant Becton, Dickinson & CO

K number K041384

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LON 2004-06-08

VITEK 2 ESBL TEST

Applicant bioMerieux, Inc.

K number K040845

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