The following data is part of a premarket notification filed by Biomerieux Sa with the FDA for Etest Ceftaroline (0.002 - 32ug/ml).
| Device ID | K151873 |
| 510k Number | K151873 |
| Device Name: | Etest Ceftaroline (0.002 - 32ug/ml) |
| Classification | Manual Antimicrobial Susceptibility Test Systems |
| Applicant | BIOMERIEUX SA 5, RUE DES AQUEDUCS Craponne, FR 69290 |
| Contact | Claire Dumas |
| Correspondent | Claire Dumas BIOMERIEUX SA 5, RUE DES AQUEDUCS Craponne, FR 69290 |
| Product Code | JWY |
| CFR Regulation Number | 866.1640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-07-09 |
| Decision Date | 2015-10-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03573026261658 | K151873 | 000 |
| 03573026624415 | K151873 | 000 |