510(k) K972725 ยท DIC Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method
ALCOHOL REAGENT SET
| Applicant | Pointe Scientific, Inc.,, Lincoln Park MI, US |
| Decision | Substantially Equivalent, Sep 25, 1997 |
| Received | Jul 21, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K972725
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.