510(k) K053577 ยท MMI Immunoassay Method, Troponin Subunit
DIMENSION VISTA CTNI FLEX FLEX REAGENT CARTRIDGE, CALIBRATOR AND SDIL SAMPLE DILUENT
| Applicant | Dade Behring, Inc., P.O. Box 6101, Newark DE, US |
| Decision | Substantially Equivalent, Apr 14, 2006 |
| Received | Dec 22, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K053577
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.