510(k) K992127 ยท MMI Immunoassay Method, Troponin Subunit
CARDIOQUANT TROPONIN I TEST
| Applicant | Spectral Diagnostics, Inc., Miami FL, US |
| Decision | Substantially Equivalent, Oct 4, 1999 |
| Received | Jun 23, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K992127
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.