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 2026-04-15

VITEK 2 AST-Streptococcus Inducible Clindamycin Resistance

Applicant bioMerieux, Inc.

K number K260282

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LON 2026-03-26

VITEK 2 AST-Streptococcus Cefuroxime (<=0.125 - >=8 µg/mL)

Applicant BIOMERIEUX

K number K260281

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LON 2025-08-21

VITEK 2 AST-Gram Negative Cefazolin (=<1-=>32 µg/mL)

Applicant bioMerieux, Inc.

K number K251579

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LON 2025-08-08

BD Phoenix Automated Microbiology System - GN Eravacycline (0.125-2 µg/mL)

Applicant Becton, Dickinson and Company

K number K251713

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LON 2025-05-19

BD Phoenix™ Automated Microbiology System - GN Imipenem-relebactam (0.0625/4 - 16/4 µg/mL)

Applicant Becton, Dickinson and Company

K number K250447

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LON 2025-03-14

VITEK COMPACT PRO

Applicant bioMerieux, Inc.

K number K234012

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LON 2025-03-06

BD Phoenix™ Automated Microbiology System

Applicant Becton, Dickinson and Company

K number K250344

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LON 2024-03-15

BD Phoenix™ Automated Microbiology System - GN Ciprofloxacin (0.0156–4 µg/mL)

Applicant Becton, Dickinson and Company

K number K233986

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LON 2024-03-11

VITEK 2 AST-Gram Positive Lefamulin (<=0.03 - >=4 µg/mL)

Applicant bioMerieux, Inc.

K number K234000

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LON 2023-12-27

Colibrí

Applicant Copan Wasp Srl

K number K232756

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LON 2023-10-23

VITEK 2 AST-Streptococcus Penicillin (<=0.06 - =>8 µg/mL), VITEK 2 Streptococcus Penicillin (<=0.06 - >=8 µg/mL), VITEK 2 Streptococcus Penicillin

Applicant bioMerieux, Inc.

K number K232201

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LON 2023-07-05

VITEK 2 AST-Gram Positive Daptomycin (<=0.12 - >=8 µg/mL), VITEK 2 AST-GP Daptomycin (<=0.12 - >=8 µg/mL), VITEK 2 AST-GP Daptomycin

Applicant bioMerieux, Inc.

K number K230864

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LON 2023-06-26

VITEK 2 AST-Gram Negative Levofloxacin (</=0.125 ->/=8 ug/mL)

Applicant bioMerieux, Inc.

K number K222378

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LON 2023-04-19

Selux AST System; Model AST Gen 1.0

Applicant Selux Diagnostics, Inc.

K number K211748

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LON 2023-03-09

VITEK 2 AST-Gram Negative Fosfomycin (<=4 - >=256 µg/mL), VITEK 2 AST-GN Fosfomycin (<=4 - >=256 µg/mL), VITEK 2 AST-GN Fosfomycin

Applicant Biomerieux Sa, Inc.

K number K222430

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LON 2023-02-16

VITEK® 2 AST-Gram Negative Plazomicin (=0.5 - =16 µg/mL); VITEK® 2 AST-GN Plazomicin (=0.5 - =16 µg/mL); VITEK® 2 AST-GN Plazomicin

Applicant bioMerieux, Inc.

K number K223478

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LON 2023-02-09

VITEK 2 AST-Gram Negative Cefazolin (<=1 - >=32 ug/mL)

Applicant bioMerieux, Inc.

K number K222073

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LON 2023-02-03

VITEK® 2 Streptococcus Tetracycline (<=0.25 - >=16 µg/mL)

Applicant bioMerieux, Inc.

K number K223481

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LON 2023-01-27

VITEK 2 AST-Gram Positive Moxifloxacin (=0.25 - =8 µg/ml), VITEK 2 AST-GP Moxifloxacin (=0.25 - =8 µg/mL), VITEK 2 AST-GP Moxifloxacin

Applicant bioMerieux, Inc.

K number K220803

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LON 2023-01-18

Selux AST System; Model AST Gen 1.0

Applicant Selux Diagnostics, Inc.

K number K211759

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LON 2022-10-13

VITEK 2 AST-Gram Positive Cefoxitin Screen

Applicant bioMerieux, Inc.

K number K220805

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LON 2022-10-05

Colibrí System

Applicant Copan Wasp Srl

K number K220546

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LON 2022-08-08

VITEK 2 AST- Gram Positive Telavancin (<=0.015 - >=1 µg/mL)

Applicant bioMerieux, Inc.

K number K212243

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LON 2022-07-12

VITEK 2 AST-Yeast Caspofungin (<=0.125 - >=8 µg/mL), VITEK 2 AST-YS Caspofungin (<=0.125 - >=8 µg/mL), VITEK 2 AST-YS Caspofungin

Applicant bioMerieux, Inc.

K number K213899

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LON 2022-06-03

VITEK 2 AST-Gram Negative Omadacycline (<=0.25 - >=16 µg/mL)

Applicant bioMerieux, Inc.

K number K213931

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LON 2022-04-14

VITEK 2 AST-Gram Negative Ciprofloxacin (?0.06 - ?4 µg/mL)

Applicant bioMerieux, Inc.

K number K214023

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LON 2022-02-25

VITEK 2 AST-Yeast Fluconazole (<=0.5->=64 µg/mL), VITEK 2 AST-YS Fluconazole (<=0.5->=64 µg/mL), VITEK 2 AST-YS Fluconazole

Applicant bioMerieux, Inc.

K number K213241

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LON 2022-02-04

VITEK 2 AST-Gram Positive Linezolid (<=0.5 – >=8 µg/mL)

Applicant Biomérieux, Inc.

K number K212849

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LON 2021-10-28

VITEK 2 AST- Streptococcus Cefotaxime (<=0.125 - =>8 ug/mL)

Applicant bioMerieux, Inc.

K number K210287

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LON 2021-09-14

VITEK 2 AST-Gram Positive Fosfomycin (<=8 - >=256 ug/mL)

Applicant bioMerieux, Inc.

K number K202396

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LON 2021-08-30

VITEK 2 AST-Gram Negative Piperacillin / Tazobactam (<=4 - =>128 µg/mL)

Applicant bioMerieux, Inc.

K number K211630

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LON 2021-07-09

VITEK 2 AST-Gram Negative Meropenem (<= 0.25 - >=16 µg/mL)

Applicant bioMerieux, Inc.

K number K201675

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LON 2021-06-14

VITEK 2 AST-Gram Negative Imipenem/Relebactam (<0.25/4 - >16/4 ug/ML)

Applicant bioMerieux, Inc.

K number K211136

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LON 2020-09-28

VITEK 2 AST-Gram Negative Ceftazidime (=<0.5 - =>32 µg/mL)

Applicant bioMerieux, Inc.

K number K193299

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LON 2020-08-30

LabPro Data Management System

Applicant Beckman Coulter, Inc.

K number K201405

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LON 2020-04-28

VITEK 2 AST-Gram Positive Delafloxacin (<=0.015 - >=1 µg/mL)

Applicant bioMerieux, Inc.

K number K200590

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LON 2020-03-13

VITEK 2 AST-Gram Negative Imipenem/Relebactam (<=0.25/4 - >=16/4 µg/mL)

Applicant bioMerieux, Inc.

K number K193572

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LON 2020-02-14

VITEK 2 AST- Gram Negative Polymyxin B (<=0.25 – >=16 ug/mL)

Applicant bioMerieux, Inc.

K number K193567

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LON 2019-10-31

Vitek Densichek

Applicant bioMerieux, Inc.

K number K192110

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LON 2019-08-05

VITEK 2 AST-Gram Negative Eravacycline (<=0.12 - >=4µg/mL)

Applicant bioMerieux, Inc.

K number K191766

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LON 2019-07-01

BD Phoenix Automated Microbiology System – GN Ceftaroline (0.0156-4 µg/mL)

Applicant Becton, Dickinson and Company

K number K190905

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LON 2019-06-06

VITEK 2 AST-Gram Positive Dalbavancin (<= 0.015 - >= 1 µg/mL)

Applicant bioMerieux, Inc.

K number K190616

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LON 2019-03-12

VITEK2 AST-Gram Negative Delafloxacin (<=0.06->=4 ug/mL)

Applicant bioMerieux, Inc.

K number K183524

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LON 2019-03-07

VITEK 2 AST-Gram Negative Minocycline (<= 0.5 - >= 32 ug/mL)

Applicant bioMerieux, Inc.

K number K183551

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LON 2019-02-26

VITEK 2 AST-Gram Negative Meropenem/Vaborbactam (<=0.5/8 – >=64/8 µg/mL)

Applicant bioMerieux, Inc.

K number K183360

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LON 2019-02-20

VITEK 2 AST-Gram Negative Imipenem (</=0.25->= 16 ug/mL)

Applicant bioMerieux, Inc.

K number K183415

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LON 2018-12-10

VITEK 2 AST-Gram Positive Inducible Clindamycin Resistance

Applicant bioMerieux, Inc.

K number K181766

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LON 2018-09-21

BD Phoenix Automated Microbiology System - BD Phoenix CPO detect - GN

Applicant Becton, Dickinson and Company

K number K181665

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LON 2018-02-09

BD Phoenix Automated Microbiology System - GN Meropenem-vaborbactam (0.125/8-32/8 ug/mL)

Applicant Becton, Dickinson and Company

K number K173523

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LON 2018-01-05

BD Phoenix Automated Microbiology System - GN Ceftolozane/tazobactam (0.25/4-32/4 ug/mL)

Applicant Becton, Dickinson and Company

K number K173252

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LON 2017-12-19

VITEK 2 AST-GN Ceftazidime/Avibactam <=0.12 – >=16 µg/mL

Applicant bioMerieux, Inc.

K number K172944

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LON 2017-12-08

VITEK 2 AST-GN Amikacin (<=1 ->=64 ug/mL)

Applicant bioMerieux, Inc.

K number K172731

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LON 2017-06-21

VITEK 2 AST-GN Ciprofloxacin (<=0.06->=4µg/mL)

Applicant bioMerieux, Inc.

K number K162737

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LON 2017-03-21

BD Phoenix Automated Microbiology System - GN Ceftazidime/avibactam (0.25/4- 32/4ug/mL)

Applicant Becton Dickinson & Company

K number K163637

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LON 2017-03-13

VITEK 2 AST-GN Gentamicin (<=1 – >=16 µg/mL)

Applicant bioMerieux, Inc.

K number K163563

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LON 2017-02-16

VITEK 2 AST Gram Negative Cefotaxime (<=0.25 - >=64 ug/mL)

Applicant bioMerieux, Inc.

K number K161437

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LON 2017-02-13

VTEK 2 AST-GN Ceftolozane/Tazobactam (<=0.25 - >= 32 mcg/mL)

Applicant bioMerieux, Inc.

K number K161510

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LON 2017-02-01

VITEK 2 AST-GN Tobramycin (</=1->/= 16 ug/mL); VITEK 2 AST-Gram Negative Tobramycin (</=1->/=16 ug/mL)

Applicant bioMerieux, Inc.

K number K163083

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LON 2017-01-24

VITEK 2 AST-GN Tigecycline (<0.5->8 ug/mL)

Applicant bioMerieux, Inc.

K number K163006

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LON 2017-01-12

VITEK 2 Gram Negative Ceftriaxone (<=0.25->=64 ug/mL)

Applicant bioMerieux, Inc.

K number K161217

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LON 2016-07-20

VITEK 2 AST-GN Cefepime (<=0.12->=32 ug/mL)

Applicant bioMerieux, Inc.

K number K161227

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LON 2016-04-15

VITEK 2 AST-Gram Negative Ertapenem (<=0.12 - >=8 ug/mL)

Applicant bioMerieux, Inc.

K number K152075

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LON 2016-01-15

BD Phoenix Automated Microbiology System-Ertapenem 0.0625-8 mcg/ml

Applicant Becton, Dickinson and Company

K number K151320

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LON 2013-12-27

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM- MEROPENEM (0.125-32 UG/ML)

Applicant Becton, Dickinson and Company

K number K132674

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LON 2013-11-15

VITEK 2 AST ST MEROPENEM

Applicant bioMerieux, Inc.

K number K132507

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LON 2013-10-10

VITEK 2 AST-ST TIGECYCLINE

Applicant bioMerieux, Inc.

K number K131779

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LON 2013-09-13

VITEK 2 AST ST MOXIFLOXACIN, VITEK 2 AST STREPTOCOCCUS MOXIFLOXACIN

Applicant bioMerieux, Inc.

K number K132573

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LON 2013-07-10

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

Applicant Becton, Dickinson & CO

K number K131331

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LON 2013-06-27

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

Applicant Becton, Dickinson & CO

K number K123404

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LON 2013-06-26

BD PHOENIX AUTOMATED MICROIOLOGY SYSTEM- ERTAPENEM 0.0625-8 UG/ML-GN

Applicant Becton, Dickinson and Company

K number K123266

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LON 2012-11-20

VITEK 2 GRAM NEGATIVE DOXYCYCLINE

Applicant bioMerieux, Inc.

K number K121546

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LON 2012-11-19

VITEK 2 AST STREPTOCOCUS VANCOMYCIN

Applicant bioMerieux, Inc.

K number K121100

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LON 2012-10-15

GRAM POSTITVE CLINDAMYCIN

Applicant bioMerieux, Inc.

K number K122547

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LON 2012-08-28

VITEK 2 STRPTOCOCCUS CEFTRIAXONE

Applicant bioMerieux, Inc.

K number K122359

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LON 2012-08-16

VITEK 2 AST-ST CEFOTAXIME

Applicant bioMerieux, Inc.

K number K121863

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LON 2012-08-07

VITEK 2 AST- GRAM POSTIVE PENICILLIN FOR STREPTOCOCCUS PNEUMONIAE

Applicant bioMerieux, Inc.

K number K113783

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LON 2012-06-29

VITEK 2 AST-GN PIPERACILLIN/TAZOBACTAM

Applicant bioMerieux, Inc.

K number K113200

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LON 2012-02-28

VITEK(R) 2 STREPTOCOCCUS TETRACYCLINE

Applicant bioMerieux, Inc.

K number K111893

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LON 2012-02-17

VITEK 2 STREPTOCOCCUS ERYTHROMYCIN

Applicant bioMerieux, Inc.

K number K111976

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LON 2012-02-10

VITEK 2 STREPTOCOCCUS TRIMETHOPRIM/SULFAMETHOXAZOLE

Applicant bioMerieux, Inc.

K number K113305

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LON 2011-11-30

VITEK 2 GRAM NEGATIVE TRIMETHOPRIM/SULFAMETHOAZOLE

Applicant bioMerieux, Inc.

K number K110106

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LON 2011-10-26

VITEK 2 STREPTOCOCCUS PENICILLIN

Applicant bioMerieux, Inc.

K number K112000

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LON 2011-10-18

VITEK 2 STREPTOCOCCUS INDUCIBLE CLINDAMYCIN RESISTANCE

Applicant bioMerieux, Inc.

K number K111909

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LON 2011-10-14

VITEK 2 SYSTEMS (PC) 5.02 SOFTWARE

Applicant bioMerieux, Inc.

K number K103752

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LON 2011-10-03

VITEK 2 STREPTOCOCCUS LEVOFLOXACIN

Applicant bioMerieux, Inc.

K number K112228

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LON 2011-09-27

VITEK(R) 2 STREPTOCOCCUS CLINDAMYCIN

Applicant bioMerieux, Inc.

K number K112129

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LON 2011-09-15

VITEK 2 STRPTOCOCCUS AMPICILLIN

Applicant bioMerieux, Inc.

K number K112075

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LON 2011-08-12

VITEK 2 AST-ST LINEZOLID

Applicant bioMerieux, Inc.

K number K111599

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LON 2010-10-21

VITEK 2 GRAM POSITIVE DOXCYCLINE

Applicant bioMerieux, Inc.

K number K093076

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LON 2009-11-09

DENSICHECK PLUS

Applicant bioMerieux, Inc.

K number K093224

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LON 2009-10-23

MICROSCAN SYNERGIES PLUS MIC/COMBO PANELS, MODEL B1025

Applicant Siemens Healthcare Diagnostics

K number K092919

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LON 2009-09-11

DENSICHEK PLUS

Applicant bioMerieux, Inc.

K number K083536

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LON 2009-08-14

VITEK 2 GRAM NEGATIVE MEROPENEM

Applicant bioMerieux, Inc.

K number K091899

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LON 2009-06-18

VITEK 2 GRAM POSITIVE DAPTOMYCIN

Applicant bioMerieux, Inc.

K number K091126

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LON 2009-03-16

VITEK 2 GRAM NEGATIVE DORIPENEM

Applicant bioMerieux, Inc.

K number K082346

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LON 2009-02-18

VITEK 2 GRAM POSITIVE ERYTHROMYCIN FOR STREPTOCOCCUS PNEUMONIAE

Applicant bioMerieux, Inc.

K number K083383

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LON 2009-01-29

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-NITROFURANTOIN (GP) 4-128 UG/ML

Applicant Becton, Dickinson & CO

K number K082852

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LON 2008-12-05

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-DOXYCYCLINE (GP) 0.25-16 UG/ML

Applicant Becton, Dickinson & CO

K number K082913

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LON 2008-11-20

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-PHOENIX INDUCIBLE MACROLIDE RESISTANCE TEST

Applicant Becton, Dickinson & CO

K number K082538

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LON 2008-04-30

VITEK 2 GRAM POSITIVE INDUCIBLE CLINDAMYCIN RESISTANCE

Applicant bioMerieux, Inc.

K number K080201

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