FDA 510(k) Applications Submitted by Esther Hernandez
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K190405 |
02/19/2019 |
BACT/ALERT MP Reagent System |
bioMerieux, Inc. |
| K211136 |
04/16/2021 |
VITEK 2 AST-Gram Negative Imipenem/Relebactam (<0.25/4 - >16/4 ug/ML) |
BioMerieux, Inc |
| K191766 |
07/01/2019 |
VITEK 2 AST-Gram Negative Eravacycline (<=0.12 - >=4╡g/mL) |
bioMerieux, Inc. |
| K222378 |
08/05/2022 |
VITEK 2 AST-Gram Negative Levofloxacin (/=8 ug/mL) |
bioMerieux, Inc. |
| K212849 |
09/07/2021 |
VITEK 2 AST-Gram Positive Linezolid (<=0.5 û >=8 ╡g/mL) |
bioMΘrieux, Inc |
| K172731 |
09/11/2017 |
VITEK 2 AST-GN Amikacin (<=1 ->=64 ug/mL) |
bioMerieux, Inc. |
| K213241 |
09/30/2021 |
VITEK 2 AST-Yeast Fluconazole (<=0.5->=64 ╡g/mL), VITEK 2 AST-YS Fluconazole (<=0.5->=64 ╡g/mL), VITEK 2 AST-YS Fluconazole |
BioMerieux, Inc. |
| K183360 |
12/04/2018 |
VITEK 2 AST-Gram Negative Meropenem/Vaborbactam (<=0.5/8 û >=64/8 ╡g/mL) |
bioMerieux, Inc |
| K213899 |
12/14/2021 |
VITEK 2 AST-Yeast Caspofungin (<=0.125 - >=8 ╡g/mL), VITEK 2 AST-YS Caspofungin (<=0.125 - >=8 ╡g/mL), VITEK 2 AST-YS Caspofungin |
bioMerieux, Inc. |
| K183524 |
12/19/2018 |
VITEK2 AST-Gram Negative Delafloxacin (<=0.06->=4 ug/mL) |
bioMerieux, Inc. |
| K193567 |
12/23/2019 |
VITEK 2 AST- Gram Negative Polymyxin B (<=0.25 û >=16 ug/mL) |
BioMerieux, Inc. |
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