The following data is part of a premarket notification filed by Biomerieux Sa with the FDA for Etest Fosfomycin (fo) (0.032-512 µg/ml).
| Device ID | K210757 |
| 510k Number | K210757 |
| Device Name: | ETEST Fosfomycin (FO) (0.032-512 µg/mL) |
| Classification | Manual Antimicrobial Susceptibility Test Systems |
| Applicant | bioMerieux SA 376, Chemin De L’Orme Marcy-l’etoile, FR 69280 |
| Contact | Marine Taravant |
| Correspondent | Marine Taravant bioMerieux SA 376, Chemin De L’Orme Marcy-l’etoile, FR 69280 |
| Product Code | JWY |
| CFR Regulation Number | 866.1640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-03-15 |
| Decision Date | 2021-11-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03573026619756 | K210757 | 000 |
| 03573026616649 | K210757 | 000 |