510(k) K955284 ยท MMI Immunoassay Method, Troponin Subunit
OPUS TROPONIN I
| Applicant | Behring Diagnostics, Inc., Westwood MA, US |
| Decision | Substantially Equivalent, Jan 25, 1996 |
| Received | Nov 16, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K955284
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.