510(k) K973616 ยท MMI Immunoassay Method, Troponin Subunit
TROPONIN I ASSAY FOR THE BAYER IMMUNO 1 SYSTEM
| Applicant | Bayer Corp., Tarrytown NY, US |
| Decision | Substantially Equivalent, Dec 5, 1997 |
| Received | Sep 23, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K973616
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.