510(k) K902483 ยท CGS Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes
CREATINE KINASE-MB TEST (MB-DS) ITEM #67655
| Applicant | Em Diagnostic Systems, Inc., Gibbstown NJ, US |
| Decision | Substantially Equivalent, Jul 10, 1990 |
| Received | Jun 5, 1990 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K902483
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.