K091109 is an FDA 510(k) clearance for the XPERT C. DIFFICILE. This device is classified as a Reagents, Clostridium Difficile Toxin (Class I - General Controls, product code LLH).
Submitted by Cepheid (Sunnyvale, US). The FDA issued a Cleared decision on July 9, 2009, 84 days after receiving the submission on April 16, 2009.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.2660.
| 510(k) Number | K091109 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 16, 2009 |
| Decision Date | July 09, 2009 |
| Days to Decision | 84 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 |