510(k) K884546 ยท CGS Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes
CREATINE KINASE TEST (CK) ITEM NUMBER: 65661
| Applicant | Em Diagnostic Systems, Inc., Gibbstown NJ, US |
| Decision | Substantially Equivalent, Feb 2, 1989 |
| Received | Oct 31, 1988 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K884546
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.