K123355 is an FDA 510(k) clearance for the AMPLIVUE C. DIFFICILE ASSAY. This device is classified as a C. Difficile Toxin Gene Amplification Assay (Class II - Special Controls, product code OZN).
Submitted by Quidel Corporation (San Diego, US). The FDA issued a Cleared decision on December 13, 2012, 43 days after receiving the submission on October 31, 2012.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3130. Amplification Assay For The Detection Of C. Difficile Toxin Genes From Stool Specimens Of Symptomatic Patients..
| 510(k) Number | K123355 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 31, 2012 |
| Decision Date | December 13, 2012 |
| Days to Decision | 43 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | OZN — C. Difficile Toxin Gene Amplification Assay |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3130 |
| Definition | Amplification Assay For The Detection Of C. Difficile Toxin Genes From Stool Specimens Of Symptomatic Patients. |