510(k) K993353 ยท MMI Immunoassay Method, Troponin Subunit
TROPONIN I ASSAY FOR THE BAYER IMMUNO 1 SYSTEM ( IN VITRO DIAGNOSTIC SYSTEM)
| Applicant | Bayer Corp., Tarrytown NY, US |
| Decision | Substantially Equivalent, Dec 6, 1999 |
| Received | Oct 5, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K993353
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.