510(k) K020950 ยท MMI Immunoassay Method, Troponin Subunit
SPECTRAL'S 2 IN 1 (TNI-MYO)
| Applicant | Spectral Diagnostics, Inc., Toronto, Ontario, CA |
| Decision | Substantially Equivalent, May 24, 2002 |
| Received | Mar 25, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K020950
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.