510(k) K123355 ยท OZN C. Difficile Toxin Gene Amplification Assay
AMPLIVUE C. DIFFICILE ASSAY
| Applicant | Quidel Corporation, San Diego CA, US |
| Decision | Substantially Equivalent, Dec 13, 2012 |
| Received | Oct 31, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K123355
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.