510(k) K894001 ยท DIC Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method
SALIVA ALCOHOL TEST
| Applicant | Enzymatics C/O Burditt,Bowles,Radzius & Ruberry, Horsham PA, US |
| Decision | Substantially Equivalent, Apr 5, 1990 |
| Received | Jun 5, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K894001
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.