510(k) K993309 ยท MMI Immunoassay Method, Troponin Subunit
BAYER DIAGNOSTICS ACS:180 AND ADVIA CENTAUR TROPONIN I ASSAY
| Applicant | Bayer Corp., Medfield MA, US |
| Decision | Substantially Equivalent, Dec 6, 1999 |
| Received | Oct 4, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K993309
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.