510(k) K913125 ยท DIC Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method
ROCHE REAGENT FOR ETHANOL
| Applicant | Roche Diagnostic Systems, Inc., Montclair NJ, US |
| Decision | Substantially Equivalent, Aug 12, 1991 |
| Received | Jul 15, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K913125
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.