510(k) K974839 ยท MMI Immunoassay Method, Troponin Subunit
ALPHA DX ANALYZER 01-0100, ALPHA DX MYO/CK/CK-MB/TNI CARDIAC PANEL TEST KIT 03-0001, ALPHA DX CK/CK-MB PANEL TEST KIT
| Applicant | First Medical, Inc., Mountain View CA, US |
| Decision | Substantially Equivalent, Feb 4, 1998 |
| Received | Dec 24, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K974839
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.