510(k) K052503 ยท MMI Immunoassay Method, Troponin Subunit
TROPONIN I ULTRA ASSAY AND CALIBRATOR FOR THE ADVIA IMS SYSTEM
| Applicant | Bayer Healthcare, LLC, Tarrytown NY, US |
| Decision | Substantially Equivalent, Dec 14, 2005 |
| Received | Sep 13, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K052503
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.