510(k) K111005 ยท DIC Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method
ETHANOL REAGENT, ETHANOL CALIBRATOR, ETHANOL QC MATERIAL
| Applicant | Medica Corp., Bedford MA, US |
| Decision | Substantially Equivalent, Nov 15, 2011 |
| Received | Apr 11, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K111005
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.