The following data is part of a premarket notification filed by Biomerieux Sa with the FDA for Rapidec Carba Np.
| Device ID | K162385 |
| 510k Number | K162385 |
| Device Name: | RAPIDEC CARBA NP |
| Classification | Phenotypic Test Kit, Non-susceptible/elevated Mic Organisms, Cultured Isolates |
| Applicant | BIOMERIEUX SA 5 RUE DES AQUEDUCS Craponne, FR 69290 |
| Contact | Asa Karlsson |
| Correspondent | Asa Karlsson BIOMERIEUX SA 5 RUE DES AQUEDUCS Craponne, FR 69290 |
| Product Code | PTJ |
| CFR Regulation Number | 866.1640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-08-25 |
| Decision Date | 2017-04-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03573026464387 | K162385 | 000 |