510(k) K012474 ยท CGS Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes
ATAC PAK CPK REAGENT KIT
| Applicant | Elan Holdings, Inc., Brea CA, US |
| Decision | Substantially Equivalent, Oct 3, 2001 |
| Received | Aug 2, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K012474
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.