510(k) K964862 ยท MMI Immunoassay Method, Troponin Subunit
TROPONIN-I TEST SYSTEM
| Applicant | Dade Intl., Inc., Miami FL, US |
| Decision | Substantially Equivalent, Feb 10, 1997 |
| Received | Dec 4, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K964862
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.