510(k) K931516 ยท DIC Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method
STC DIAGNOSTICS AUTO-LYTE(TM) ETHYL ALCOHOL ASSAY
| Applicant | Solarcare Technologies Corp,Inc., Bethlehem PA, US |
| Decision | Substantially Equivalent, Jul 19, 1993 |
| Received | Mar 26, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K931516
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.