510(k) K861061 ยท CGS Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes
EMDS CREATINE KINASE ISOENZYME CKMB TEST PACK
| Applicant | Em Diagnostic Systems, Inc., Gibbstown NJ, US |
| Decision | Substantially Equivalent, Apr 24, 1986 |
| Received | Mar 20, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K861061
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.