510(k) K030950 ยท MMI Immunoassay Method, Troponin Subunit
VIDAS TROPONIN I (TNI), MODEL 30 445
| Applicant | bioMerieux, Inc., Hazelwood MO, US |
| Decision | Substantially Equivalent, Jun 16, 2003 |
| Received | Mar 26, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K030950
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.