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 2004-05-28

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CONFIRMATORY ESBL TEST

Applicant Becton, Dickinson & CO

K number K033458

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LON 2004-05-14

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-PENICILLIN (GP) 0.0625-32 UG/ML

Applicant Becton, Dickinson & CO

K number K040716

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LON 2004-04-09

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - TRIMETHOPRIM-SULFAMETHOXAZOLE 0.5/9.5 - 16/304 UG/ML

Applicant Becton, Dickinson & CO

K number K033907

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LON 2004-04-09

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM- CEFUROXIME GRAM NEGATIVE

Applicant Becton, Dickinson & CO

K number K033362

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LON 2004-04-02

MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH CEPHALOTHIN (0.5-32 UG/ML)

Applicant Dade Behring, Inc.

K number K031601

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LON 2004-03-19

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM

Applicant Becton, Dickinson & CO

K number K040099

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LON 2004-03-11

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM -- AMPICILLIN -- GRAM POSITIVE

Applicant Becton, Dickinson & CO

K number K040106

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LON 2004-03-01

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-CEFEPIME (GN) 0.5-65 UG/ML

Applicant Becton, Dickinson & CO

K number K032675

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LON 2004-02-27

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-LINEZOLID-GRAM POSITIVE

Applicant Becton, Dickinson & CO

K number K040006

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LON 2004-02-03

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM FOR USE WITH THE ANTIMICROBIAL AGENT CHLORAMPHENICOL 1-32 UG/ML GRAM POSITIVE

Applicant Becton, Dickinson & CO

K number K033889

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LON 2004-02-03

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - ERYTHROMYCIN 0.0625-8 UG/ML

Applicant Becton, Dickinson & CO

K number K033784

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LON 2004-01-14

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFTAZIDIME 0.5-64 UG/ML-GRAM-NEGATIVE ID/AST OR AST ONLY PHOENIX PANELS

Applicant Becton, Dickinson & CO

K number K033560

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LON 2004-01-14

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - TICARCILLIN/CLAVULANATE-GRAM NEGATIVE

Applicant Becton, Dickinson & CO

K number K033557

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LON 2003-12-19

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - AZTREONAM 0.5-64 UG/ML-GRAM-NEGATIVE ID/AST OR AST ONLY PHOENIX PANELS

Applicant Becton, Dickinson & CO

K number K033558

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LON 2003-11-26

MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH AMPICILLIN (0.25-128 UG/ML)

Applicant Dade Behring, Inc.

K number K033482

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LON 2003-11-26

MYCOPLASMA IGG

Applicant Trinity Biotech USA

K number K033064

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LON 2003-11-12

VITEK 2 GRAM NEGATIVE MOXIFLOXACIN

Applicant bioMerieux, Inc.

K number K032861

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LON 2003-11-04

VITEK 2 GRAM NEGATIVE GATIFLOXACIN

Applicant bioMerieux, Inc.

K number K032788

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LON 2003-10-31

VITEK 2 GRAM POSITIVE LINEZOLID

Applicant bioMerieux, Inc.

K number K032766

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LON 2003-10-31

VITEK 2 GRAM POSITIVE QUINUPRISTIN/DALFOPRISTIN

Applicant bioMerieux, Inc.

K number K032738

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LON 2003-10-31

VITEK GRAM NEGATIVE GATIFLOXACIN

Applicant bioMerieux, Inc.

K number K032711

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LON 2003-10-06

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

Applicant Becton, Dickinson & CO

K number K032655

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LON 2003-09-29

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-IMIPENEM 1-16 UG/ML GRAM-NEGATIVE ID/AST OR AST ONLY PHOENIX PANELS

Applicant Becton, Dickinson & CO

K number K032275

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LON 2003-09-22

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM,-AMPICILLIN 0.5.-32 UG/ML

Applicant Becton, Dickinson & CO

K number K032299

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LON 2003-09-17

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-CEFOXITIN-GRAM NEGATIVE

Applicant Becton, Dickinson & CO

K number K032567

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LON 2003-09-11

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

Applicant Bd Diagnostic Systems

K number K032153

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LON 2003-09-10

VITEK 2 GRAM POSITIVE MOXIFLOXACIN

Applicant bioMerieux, Inc.

K number K032399

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LON 2003-08-27

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

Applicant Becton, Dickinson & CO

K number K031984

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LON 2003-08-22

VITEK 2 GRAM POSITIVE GATIFLOXACIN

Applicant bioMerieux, Inc.

K number K032314

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LON 2003-08-18

BD AUTOMATED MICROBIOLOGY SYSTEM TETRACYCLINE - GP 0.5-16 UG/ML-GRAM POSITIVE ID/AST OR AST ONLY PHOENIX PANELS

Applicant Becton, Dickinson & CO

K number K032131

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LON 2003-08-13

VITEK 2 GRAM POSITIVE MOXIFLOXACIN FOR STREPOCOCCUS PNEUMONIAE

Applicant bioMerieux, Inc.

K number K031865

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LON 2003-08-06

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

Applicant Becton, Dickinson & CO

K number K031943

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LON 2003-07-31

MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH NITROFURANTOIN (1-256 UG/ML)

Applicant Dade Behring, Inc.

K number K031602

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LON 2003-07-30

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - TRIMETHOPRIM-SULFAMETHOXAZOLE 0.5/9.5-16/304UG/ML

Applicant Becton, Dickinson & CO

K number K031699

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LON 2003-07-21

BD PHOENIX AUTOMATED MICRBIOLOGY SYSTEM AMOXICILLIN/CLAVUALANTE 0.5/0.25-32/16 UG/ML

Applicant Becton, Dickinson & CO

K number K031912

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LON 2003-07-16

BD PHONENIX AUTOMATED MICROBIOLOGY SYSTEM

Applicant Becton, Dickinson & CO

K number K031679

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LON 2003-07-11

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-NITROFURANTOIN GRAM POSITIVE

Applicant Becton, Dickinson & CO

K number K031589

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LON 2003-07-10

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-NITROFURANTOIN-8-512 UG/ML

Applicant Becton, Dickinson & CO

K number K031530

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LON 2003-07-10

VITEK 2 GRAM POSITIVE LINEZOLID FOR STREPTOCOCCUS PNEUMONIAE

Applicant bioMerieux, Inc.

K number K031410

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LON 2003-06-06

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-MEROPENEM 0.25-16 UG/ML

Applicant Bd Diagnostic Systems

K number K031429

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LON 2003-06-02

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - MOXIFLOXACIN GRAM POSITIVE

Applicant Becton, Dickinson & CO

K number K031306

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LON 2003-05-16

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM TRIMETHOPRIM - GN 0.5-16 UG/ML

Applicant Becton, Dickinson & CO

K number K030986

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LON 2003-04-01

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-VANCOMYCIN GRAM POSITIVE

Applicant Becton, Dickinson & CO

K number K030677

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LON 2003-03-21

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-NALIDIXIC ACID - 2-32 UG/ML

Applicant Becton, Dickinson & CO

K number K030579

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LON 2003-02-28

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - NORFLOXACIN 0.25 - 16 UG/ML

Applicant Bd Diagnostic Systems

K number K030091

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LON 2003-02-10

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - TETRACYCLINE - 0.5-16 UG/ML

Applicant Becton, Dickinson & CO

K number K024153

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LON 2003-01-31

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - RIFAMPIN 0.25-32 UG/ML

Applicant Becton, Dickinson & CO

K number K024152

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LON 2003-01-24

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM

Applicant Becton, Dickinson & CO

K number K023568

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LON 2003-01-08

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CIPROFLOXACIN GN

Applicant Becton, Dickinson & CO

K number K023895

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LON 2002-12-24

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-GENTAMICIN GN (0.25-16UG/ML)

Applicant Becton, Dickinson & CO

K number K023634

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LON 2002-12-23

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - NORFLOXACIN - 0.25-16 UG/ML

Applicant Becton, Dickinson & CO

K number K023527

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LON 2002-12-20

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM

Applicant Becton, Dickinson & CO

K number K023858

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LON 2002-12-16

MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH GATIFLOXACIN (0.004-16 UG/ML)

Applicant Dade Behring, Inc.

K number K023361

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LON 2002-12-13

MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH MOXIFLOXACIN (0.004-16UG/ML)

Applicant Dade Behring, Inc.

K number K023541

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LON 2002-11-12

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

Applicant Becton, Dickinson & CO

K number K023444

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LON 2002-11-12

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM

Applicant Becton, Dickinson & CO

K number K023301

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LON 2002-10-31

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - GENTAMICIN 0.25 - 16 UG/ML

Applicant Becton, Dickinson & CO

K number K023273

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LON 2002-08-15

VITEK GRAM POSITIVE SUSCEPTIBILITY (GPS) CARD FOR LINEZOLID

Applicant bioMerieux, Inc.

K number K022045

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LON 2002-08-12

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM

Applicant Becton, Dickinson & CO

K number K022172

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LON 2002-08-01

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-CLINDAMYCIN 0.125-8.0MCG/ML

Applicant Becton, Dickinson & CO

K number K021954

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LON 2002-07-25

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM MOXIFLOXACIN 0.125-8 UG/ML

Applicant Becton, Dickinson & CO

K number K022129

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LON 2002-07-17

MICROSCAN SYNERGIES PLUS DRIED GRAM NEGATIVE MIC/COMBO PANELS WITH CEFTAZIDIME (1-16 UG/ML)

Applicant Dade Behring, Inc.

K number K020413

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LON 2002-06-11

MICROSCAN RAPID/S PLUS GRAM-NEGATIVE MIC/COMBO PANELS WITH CEPHALOTHIN (2-64 UG/ML)

Applicant Dade Behring, Inc.

K number K020410

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LON 2002-05-23

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM

Applicant Becton, Dickinson & CO

K number K020321

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LON 2002-05-16

MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH AMPICILLIN (0.25-128 UG/ML)

Applicant Dade Behring, Inc.

K number K020398

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LON 2002-04-22

MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH PIPERACILLIN (4-256 UG/ML)

Applicant Dade Behring, Inc.

K number K020397

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LON 2002-04-17

MICROSCAN SYNERGIES PLUS GRAM-NEGATIVE MIC/COMBO PANELS WITH CEFTRIAXONE (0.5-128 UG/ML)

Applicant Dade Microscan, Inc.

K number K020506

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LON 2002-04-17

MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH AMPICILLIN/SULBACTAM (0.5/0.25-64/34 UG/ML)

Applicant Dade Behring, Inc.

K number K020319

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LON 2002-04-04

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM

Applicant Becton, Dickinson & CO

K number K020323

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LON 2002-03-29

VITEK 2 ANTIMIRCROBIAL SUSCEPTIBILITY TEST SYSTEM FOR LEVOFLOXACIN

Applicant bioMerieux, Inc.

K number K020871

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LON 2002-03-27

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM

Applicant Becton, Dickinson & CO

K number K020322

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LON 2002-03-25

VITEK 2 ANTIMICROBIAL SUSCEPTIBILITY TEST SYTEM FOR SPARFLOXACIN

Applicant bioMerieux, Inc.

K number K020870

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LON 2002-03-14

MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH TRIMETHOPRIM/SULFAMETHOXAZOLE (0.25/4.75-64/1216 UG/ML)

Applicant Dade Behring, Inc.

K number K020248

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LON 2002-03-14

MICROSCAN SYNERGIES PLUS

Applicant Dade Behring, Inc.

K number K020142

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LON 2002-03-06

MICROSCAN SYNERGIES PLUS

Applicant Dade Microscan, Inc.

K number K020511

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LON 2002-02-19

MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH CEFUROXIME (1-64 UG/ML)

Applicant Dade Behring, Inc.

K number K020328

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LON 2002-02-06

MICROSCAN PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH MEROPENEM (0.12-32 UG/ML)

Applicant Dade Behring, Inc.

K number K020249

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LON 2002-02-06

MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH IMIPENEM (0.25, 1-32 UG/ML)

Applicant Dade Behring, Inc.

K number K020246

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LON 2002-02-06

MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH AMIKACIN (0.25-128 UG/ML)

Applicant Dade Behring, Inc.

K number K020209

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LON 2002-02-06

MICROSCAN RAPID/S PLUS GRAM-NEGATIVE MIC COMBO PANELS WITH GENTAMICIN (0.12-32 UG/ML)

Applicant Dade Behring, Inc.

K number K020185

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LON 2002-02-06

MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH NETILMICIN (0.12-32 UG/ML)

Applicant Dade Behring, Inc.

K number K020182

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LON 2002-02-06

MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH TETRACYCLINE (0.12-128 UG/ML)

Applicant Dade Behring, Inc.

K number K020173

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LON 2002-02-06

MICROSCAN SYNERGIS PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH TOBRAMYCIN (0.12-32 UG/ML)

Applicant Dade Behring, Inc.

K number K020168

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LON 1989-06-02

SCEPTOR DATA MANAGEMENT CENTER SOFTWARE

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K number K891577

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LON 1986-08-01

REPLIANALYZER

Applicant Mct Medical, Inc.

K number K861958

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