K112048 is an FDA 510(k) clearance for the IMMUNOCARD C. DIFFICILE GDH. This device is classified as a Antigen, C. Difficile (Class I - General Controls, product code MCB).
Submitted by Meridian Bioscience, Inc. (Cincinnati, US). The FDA issued a Cleared decision on December 16, 2011, 151 days after receiving the submission on July 18, 2011.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.2660.
| 510(k) Number | K112048 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 18, 2011 |
| Decision Date | December 16, 2011 |
| Days to Decision | 151 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 |