510(k) K951890 ยท MMI Immunoassay Method, Troponin Subunit
STRATUS CARDIAC TROPONIN-I FLUOROMETRIC ENZYME IMMUNMNOASSAY & STRATUS CARDIAC TROPONIN-I CALIBRATORS
| Applicant | Dade Intl., Inc., Miami FL, US |
| Decision | Substantially Equivalent, Jul 13, 1995 |
| Received | Apr 24, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K951890
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.