510(k) K050975 ยท MMI Immunoassay Method, Troponin Subunit
NANO-CHECK AMI 3 IN 1 CARDIAC DISEASE TEST FOR CARDIAC TROPONIN I, CREATINE KINASE MB AND MYOGLOBIN
| Applicant | Nano-Ditech Co., Great Neck NY, US |
| Decision | Substantially Equivalent, Mar 2, 2006 |
| Received | Apr 18, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K050975
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.