510(k) K123998 ยท OZN C. Difficile Toxin Gene Amplification Assay
QUIDEL MOLECULAR DIRECT C. DIFFICILE ASSAY
| Applicant | Quidel Corp., San Diego CA, US |
| Decision | Substantially Equivalent, Mar 8, 2013 |
| Received | Dec 26, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K123998
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.