510(k) K070853 ยท DIC Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method
DIMENSION VISTA ETOH FLEX REAGENT CARTRIDGE, MODEL K5022
| Applicant | Dade Behring, Inc., Newark DE, US |
| Decision | Substantially Equivalent, Jun 13, 2007 |
| Received | Mar 28, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K070853
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.