510(k) K972011 ยท DIC Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method
OPUS ETHANOL
| Applicant | Behring Diagnostics, Inc., Westwood MA, US |
| Decision | Substantially Equivalent, Jul 22, 1997 |
| Received | May 30, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K972011
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.