The following data is part of a premarket notification filed by Biomerieux Sa with the FDA for Vidas C Difficile Gdh.
| Device ID | K132010 |
| 510k Number | K132010 |
| Device Name: | VIDAS C DIFFICILE GDH |
| Classification | Antigen, C. Difficile |
| Applicant | BIOMERIEUX SA 5 RUE DES AQUEDUCS Craponne, FR 69290 |
| Contact | Caroline Koch-mathian |
| Correspondent | Caroline Koch-mathian BIOMERIEUX SA 5 RUE DES AQUEDUCS Craponne, FR 69290 |
| Product Code | MCB |
| CFR Regulation Number | 866.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-07-01 |
| Decision Date | 2013-10-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03573026444204 | K132010 | 000 |