510(k) K010960 ยท DIC Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method
EMIT II PLUS ETHYL ALCOHOL ASSAY, MODEL OSR9K229
| Applicant | Syva Co., Dade Behring, Inc., San Jose CA, US |
| Decision | Substantially Equivalent, Apr 26, 2001 |
| Received | Mar 30, 2001 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K010960
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.