510(k) K964372 ยท MMI Immunoassay Method, Troponin Subunit
CARDIAC T TROPONIN T RAPID ASSAY
| Applicant | Boehringer Mannheim Corp., Indianapolis IN, US |
| Decision | Substantially Equivalent, Feb 10, 1997 |
| Received | Nov 1, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K964372
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.