K132010 is an FDA 510(k) clearance for the VIDAS C DIFFICILE GDH. This device is classified as a Antigen, C. Difficile (Class I - General Controls, product code MCB).
Submitted by Biomerieux S.A. (Craponne, FR). The FDA issued a Cleared decision on October 9, 2013, 100 days after receiving the submission on July 1, 2013.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.2660.
| 510(k) Number | K132010 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 01, 2013 |
| Decision Date | October 09, 2013 |
| Days to Decision | 100 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | MCB - Antigen, C. Difficile |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.2660 |