Biomerieux S.A.
FDA 510(k) & PMA Approved Devices — 10 products
Total Devices10
Categories3
Latest FDA decision2025-04-30
| Type | Number | Device Name | Code | Date | Actions |
|---|---|---|---|---|---|
| 510(k) | K250274 | ETEST Imipenem/Relebactam P. aeruginosa (IRPA) (0.008/4-128/4 µg/mL) | JWY | 2025-04-30 | View |
| 510(k) | K210757 | ETEST Fosfomycin (FO) (0.032-512 µg/mL) | JWY | 2021-11-12 | View |
| 510(k) | K192738 | ETEST Delafloxacin (DFX) (0.002-32 µg/mL) | JWY | 2019-11-26 | View |
| 510(k) | K192050 | ETEST Eravacycline (ERV) (0.002 – 32 µg/mL) | JWY | 2019-09-27 | View |
| 510(k) | K191953 | ETEST Imipenem/Relebactam (IPR) (0.002/4-32/4 ug/mL) | JWY | 2019-08-22 | View |
| 510(k) | K190154 | ETEST Piperacillin/Tazobactam (P/T) (0.016/4-256/4 ug/mL) | JWY | 2019-05-01 | View |
| 510(k) | K183031 | ETEST Meropenem/Vaborbactam (MEV) (0.004/8-64/8 µg/mL) | JWY | 2019-01-11 | View |
| 510(k) | K181092 | CHROMID CARBA agar (CARB) | JSO | 2018-07-06 | View |
| 510(k) | K180936 | ETEST Telavancin (TLA) (0.002-32 ug/mL) | JWY | 2018-07-03 | View |
| 510(k) | K162385 | RAPIDEC CARBA NP | PTJ | 2017-04-27 | View |
No matching devices.