510(k) K963513 ยท MMI Immunoassay Method, Troponin Subunit
CARDIAC STATUS TROPONIN I
| Applicant | Princeton BioMeditech Corp., Monmouth Junction NJ, US |
| Decision | Substantially Equivalent, Nov 7, 1996 |
| Received | Sep 3, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K963513
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.