510(k) K063243 ยท MMI Immunoassay Method, Troponin Subunit
VIDAS TROPONIN I ULTRA (TNIU) ASSAY, MODEL 30 448
| Applicant | bioMerieux, Inc., Hazelwood MO, US |
| Decision | Substantially Equivalent, Dec 14, 2007 |
| Received | Oct 26, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K063243
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.