510(k) K014105 ยท MMI Immunoassay Method, Troponin Subunit
SPECTRAL'S TROPONIN I
| Applicant | Spectral Diagnostics, Inc., Toronto, Ontario, CA |
| Decision | Substantially Equivalent, Feb 1, 2002 |
| Received | Dec 13, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K014105
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.