510(k) K010201 ยท MMI Immunoassay Method, Troponin Subunit
BAYER ADVIA IMS SYSTEM
| Applicant | Bayer Corp., Tarrytown NY, US |
| Decision | Substantially Equivalent, Mar 29, 2001 |
| Received | Jan 22, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K010201
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.