bioMerieux, Inc. - FDA 510(k) Cleared Devices
250
Total
249
Cleared
1
Denied
205 devices
Cleared
Apr 28, 2020
VITEK 2 AST-Gram Positive Delafloxacin (<=0.015 - >=1 µg/mL)
Microbiology
53d
Cleared
Mar 13, 2020
VITEK 2 AST-Gram Negative Imipenem/Relebactam (<=0.25/4 - >=16/4 µg/mL)
Microbiology
81d
Cleared
Feb 14, 2020
VITEK 2 AST- Gram Negative Polymyxin B (<=0.25 – >=16 ug/mL)
Microbiology
53d
Cleared
Oct 31, 2019
Vitek Densichek
Microbiology
87d
Cleared
Aug 05, 2019
VITEK 2 AST-Gram Negative Eravacycline (<=0.12 - >=4µg/mL)
Microbiology
35d
Cleared
Jun 06, 2019
VITEK 2 AST-Gram Positive Dalbavancin (<= 0.015 - >= 1 µg/mL)
Microbiology
87d
Cleared
May 15, 2019
BACT/ALERT MP Reagent System
Microbiology
85d
Cleared
Mar 12, 2019
VITEK2 AST-Gram Negative Delafloxacin (<=0.06->=4 ug/mL)
Microbiology
83d
Cleared
Mar 07, 2019
VITEK 2 AST-Gram Negative Minocycline (<= 0.5 - >= 32 ug/mL)
Microbiology
77d
Cleared
Feb 26, 2019
VITEK 2 AST-Gram Negative Meropenem/Vaborbactam (<=0.5/8 – >=64/8 µg/mL)
Microbiology
84d
Cleared
Feb 20, 2019
VITEK 2 AST-Gram Negative Imipenem (= 16 ug/mL)
Microbiology
72d
Cleared
Feb 11, 2019
BacT/ALERT FA Plus
Microbiology
88d
Cleared
Dec 21, 2018
VITEK MS
Microbiology
205d
Cleared
Dec 10, 2018
VITEK 2 AST-Gram Positive Inducible Clindamycin Resistance
Microbiology
160d
Cleared
Jun 20, 2018
VITEK 2 AST-YS Micafungin (<=0.06 - =>8 µg/mL)
Microbiology
28d
Cleared
Dec 19, 2017
VITEK 2 AST-GN Ceftazidime/Avibactam <=0.12 – >=16 µg/mL
Microbiology
84d
Cleared
Dec 08, 2017
VITEK 2 AST-GN Amikacin (<=1 ->=64 ug/mL)
Microbiology
88d
Cleared
Sep 15, 2017
Etest Ceftazidime/Avibactam (CZA) (0.016 - 256 ug/mL)
Microbiology
60d
Cleared
Jul 22, 2017
VITEK MS
Microbiology
271d
Cleared
Jun 21, 2017
VITEK 2 AST-GN Ciprofloxacin (<=0.06->=4µg/mL)
Microbiology
264d
Cleared
May 31, 2017
Etest Ceftolozane/ Tazobactam (0.016-256 ug/ml)
Microbiology
86d
Cleared
Mar 28, 2017
BacT/ALERT VIRTUO Microbial Detection System, BacT/ALERT VIRTUO, VIRTUO
Microbiology
270d
Cleared
Mar 13, 2017
VITEK 2 AST-GN Gentamicin (<=1 – >=16 µg/mL)
Microbiology
84d
Cleared
Feb 23, 2017
VIDAS B.R.A.H.M.S. PCT (PCT)
Microbiology
139d
Cleared
Feb 16, 2017
VITEK 2 AST Gram Negative Cefotaxime (<=0.25 - >=64 ug/mL)
Microbiology
268d
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