510(k) K013912 ยท CGS Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes
CREATINE KINASE (CK-NAC)
| Applicant | Jas Diagnostics, Inc., Miami FL, US |
| Decision | Substantially Equivalent, Jan 18, 2002 |
| Received | Nov 27, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K013912
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.