510(k) K023296 ยท DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites
COBAS INTEGRA ONLINE DAT II COCAINE II
| Applicant | Roche Diagnostics Corp., Indianapolis IN, US |
| Decision | Substantially Equivalent, Nov 25, 2002 |
| Received | Oct 2, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K023296
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.