510(k) K914361 ยท CGS Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes
CREATINE KINASE MB TEST ITEM NUMBER 5A46
| Applicant | Em Diagnostic Systems, Inc., Gibbstown NJ, US |
| Decision | Substantially Equivalent, Dec 13, 1991 |
| Received | Oct 1, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K914361
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.