Biomérieux SA
Medical device manufacturer in Marcy-L'Etoile, FR.
6510(k) clearances
0PMA approvals
0recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K260447 | ETEST Gepotidacin (GEP) (0.016-256 µg/mL)JWY · Traditional | 04/21/2026SE |
| K250856 | ETEST Aztreonam/Avibactam (AZA) (0.016/4-256/4 µg/mL)JWY · Traditional | 06/12/2025SE |
| K232395 | ETEST® Sulbactam/Durlobactam (SUD) (0.004/4-64/4 µg/mL), ETEST® SUDJWY · Traditional | 10/05/2023SE |
| K210793 | Vidas NephrocheckPIG · Traditional | 07/08/2022SE |
| K212849 | VITEK 2 AST-Gram Positive Linezolid (<=0.5 >=8 µg/mL)LON · Special | 02/04/2022SE |
| K200512 | ETEST Plazomicin (PLZ) (0.016-256 µg/mL)JWY · Traditional | 05/07/2020SE |