The following data is part of a premarket notification filed by Biomerieux, Inc. with the FDA for Etest Ceftaroline.
| Device ID | K121002 |
| 510k Number | K121002 |
| Device Name: | ETEST CEFTAROLINE |
| Classification | Manual Antimicrobial Susceptibility Test Systems |
| Applicant | BIOMERIEUX, INC. 595 ANGLUM RD. Hazelwood, MO 63042 |
| Contact | Jennifer Chia-hsuan Lin |
| Correspondent | Jennifer Chia-hsuan Lin BIOMERIEUX, INC. 595 ANGLUM RD. Hazelwood, MO 63042 |
| Product Code | JWY |
| CFR Regulation Number | 866.1640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-04-02 |
| Decision Date | 2012-10-12 |
| Summary: | summary |