510(k) K010488 ยท CIT Nadh Oxidation/Nad Reduction, Ast/Sgot
ATAC PAK AST REAGENT KIT
| Applicant | Elan Holdings, Inc., Brea CA, US |
| Decision | Substantially Equivalent, Apr 9, 2001 |
| Received | Feb 20, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K010488
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.