FDA 510(k) Applications Submitted by BioMerieux, Inc
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K210287 |
02/02/2021 |
VITEK 2 AST- Streptococcus Cefotaxime (<=0.125 - =>8 ug/mL) |
bioMerieux, Inc |
| K152075 |
07/27/2015 |
VITEK 2 AST-Gram Negative Ertapenem (<=0.12 - >=8 ug/mL) |
bioMerieux, Inc |
| K200590 |
03/06/2020 |
VITEK 2 AST-Gram Positive Delafloxacin (<=0.015 - >=1 ╡g/mL) |
bioMerieux, Inc |
| K220803 |
03/18/2022 |
VITEK 2 AST-Gram Positive Moxifloxacin (=0.25 - =8 ╡g/ml), VITEK 2 AST-GP Moxifloxacin (=0.25 - =8 ╡g/mL), VITEK 2 AST-GP Moxifloxacin |
bioMerieux, Inc |
| K161227 |
05/02/2016 |
VITEK 2 AST-GN Cefepime (<=0.12->=32 ug/mL) |
BIOMERIEUX, INC |
| K161510 |
06/01/2016 |
VTEK 2 AST-GN Ceftolozane/Tazobactam (<=0.25 - >= 32 mcg/mL) |
BIOMERIEUX, INC |
| K181766 |
07/03/2018 |
VITEK 2 AST-Gram Positive Inducible Clindamycin Resistance |
bioMerieux, Inc |
| K172150 |
07/17/2017 |
Etest Ceftazidime/Avibactam (CZA) (0.016 - 256 ug/mL) |
bioMerieux, Inc |
| K212243 |
07/19/2021 |
VITEK 2 AST- Gram Positive Telavancin (<=0.015 - >=1 ╡g/mL) |
bioMerieux, Inc |
| K162737 |
09/30/2016 |
VITEK 2 AST-GN Ciprofloxacin (<=0.06->=4╡g/mL) |
bioMerieux, Inc |
| K223478 |
11/18/2022 |
VITEK« 2 AST-Gram Negative Plazomicin (=0.5 - =16 ╡g/mL); VITEK« 2 AST-GN Plazomicin (=0.5 - =16 ╡g/mL); VITEK« 2 AST-GN Plazomicin |
bioMerieux, Inc |
| K163563 |
12/19/2016 |
VITEK 2 AST-GN Gentamicin (<=1 û >=16 ╡g/mL) |
bioMerieux, Inc |
| K220805 |
03/18/2022 |
VITEK 2 AST-Gram Positive Cefoxitin Screen |
bioMerieux, Inc |
| K211136 |
04/16/2021 |
VITEK 2 AST-Gram Negative Imipenem/Relebactam (<0.25/4 - >16/4 ug/ML) |
BioMerieux, Inc |
| K183360 |
12/04/2018 |
VITEK 2 AST-Gram Negative Meropenem/Vaborbactam (<=0.5/8 û >=64/8 ╡g/mL) |
bioMerieux, Inc |
| K230864 |
03/29/2023 |
VITEK 2 AST-Gram Positive Daptomycin (<=0.12 - >=8 ╡g/mL), VITEK 2 AST-GP Daptomycin (<=0.12 - >=8 ╡g/mL), VITEK 2 AST-GP Daptomycin |
BioMerieux, Inc |
| K223481 |
11/18/2022 |
VITEK« 2 Streptococcus Tetracycline (<=0.25 - >=16 ╡g/mL) |
bioMerieux, Inc |
| K192110 |
08/05/2019 |
Vitek Densichek |
bioMerieux, Inc |
| K162827 |
10/07/2016 |
VIDAS B.R.A.H.M.S. PCT (PCT) |
bioMerieux, Inc |
| K214023 |
12/22/2021 |
VITEK 2 AST-Gram Negative Ciprofloxacin (?0.06 - ?4 ╡g/mL) |
bioMerieux, Inc |
| K222073 |
07/14/2022 |
VITEK 2 AST-Gram Negative Cefazolin (<=1 - >=32 ug/mL) |
bioMerieux, Inc |
| K211630 |
05/27/2021 |
VITEK 2 AST-Gram Negative Piperacillin / Tazobactam (<=4 - =>128 ╡g/mL) |
bioMerieux, Inc |
| K160911 |
04/01/2016 |
VIDAS B.R.A.H.M.S. PCT (PCT) |
bioMerieux, Inc |
|
|
