510(k) K973650 ยท MMI Immunoassay Method, Troponin Subunit
TROPONIN (TROP) METHOD
| Applicant | Dade Chemistry Systems, Inc., Glasgow DE, US |
| Decision | Substantially Equivalent, Oct 20, 1997 |
| Received | Sep 25, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K973650
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.