510(k) K023184 ยท DIC Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method
ETHANOL ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM
| Applicant | Bayer Diagnostics Corp., Tarrytown NY, US |
| Decision | Substantially Equivalent, Nov 18, 2002 |
| Received | Sep 24, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K023184
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.