510(k) K010562 ยท MMI Immunoassay Method, Troponin Subunit
ALPHA DX SYSTEM
| Applicant | First Medical, Inc., Irvine CA, US |
| Decision | Substantially Equivalent, Mar 13, 2001 |
| Received | Feb 26, 2001 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K010562
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.