510(k) K854130 ยท DIC Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method
DEMAND ETHYL ALCOHOL
| Applicant | Cooper Biomedical, Inc., Malvern PA, US |
| Decision | Substantially Equivalent, Nov 5, 1985 |
| Received | Oct 9, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K854130
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.