510(k) K903235 ยท DIC Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method
STATLAB A-350 SALIVA ALCOHOL TEST
| Applicant | Enzymatics C/O Burditt,Bowles,Radzius & Ruberry, Horsham PA, US |
| Decision | Substantially Equivalent, Oct 12, 1990 |
| Received | Jul 23, 1990 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K903235
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.