510(k) K030057 ยท MMI Immunoassay Method, Troponin Subunit
SPECTRAL CARDIAC STATUS CK-MB/MYOGLOBIN/TROPONIN I 3-IN-1 TEST
| Applicant | Spectral Diagnostics, Inc., Toronto, Ontario, CA |
| Decision | Substantially Equivalent, Mar 19, 2003 |
| Received | Jan 7, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K030057
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.