510(k) K884547 ยท CGS Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes
CREATINE KINASE-MB TEST (CK-MK) ITEM NUMBER 65673
| Applicant | Em Diagnostic Systems, Inc., Gibbstown NJ, US |
| Decision | Substantially Equivalent, Feb 10, 1989 |
| Received | Oct 31, 1988 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K884547
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.