The following data is part of a premarket notification filed by Biomérieux S.a. with the FDA for Etest Plazomicin (plz) (0.016-256 µg/ml).
| Device ID | K200512 |
| 510k Number | K200512 |
| Device Name: | ETEST Plazomicin (PLZ) (0.016-256 µg/mL) |
| Classification | Manual Antimicrobial Susceptibility Test Systems |
| Applicant | bioMérieux S.A. 376 Chemin De L'Orme Marcy L'etoile, FR 69280 |
| Contact | Alexia Bosquet |
| Correspondent | Alexia Bosquet bioMérieux S.A. 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 | 2020-03-02 |
| Decision Date | 2020-05-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03573026560911 | K200512 | 000 |