K072138 is an FDA 510(k) clearance for the VIDAS C. DIFFICILE TOXIN A&B (CDAB) ASSAY, MODEL: 30 118. This device is classified as a Reagents, Clostridium Difficile Toxin (Class I - General Controls, product code LLH).
Submitted by bioMerieux, Inc. (Hazelwood, US). The FDA issued a Cleared decision on December 21, 2007, 141 days after receiving the submission on August 2, 2007.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.2660.
| 510(k) Number | K072138 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 02, 2007 |
| Decision Date | December 21, 2007 |
| Days to Decision | 141 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | LLH — Reagents, Clostridium Difficile Toxin |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.2660 |