510(k) K843109 ยท CIT Nadh Oxidation/Nad Reduction, Ast/Sgot
ROCHE REAGENT FOR AST
| Applicant | Roche Diagnostic Systems, Inc., Nutley NJ, US |
| Decision | Substantially Equivalent, Nov 5, 1984 |
| Received | Aug 7, 1984 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K843109
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.