510(k) K132726 ยท OZN C. Difficile Toxin Gene Amplification Assay
ICEPLEX C. DIFFICILE ASSAY KIT, ICEPLEX SYSTEM
| Applicant | Primeradx, Mansfield MA, US |
| Decision | Substantially Equivalent, Nov 29, 2013 |
| Received | Aug 30, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K132726
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.