510(k) K863843 ยท DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites
COCAINE METABOLITE ROCHE(R) EIA
| Applicant | Roche Diagnostic Systems, Inc., Nutley NJ, US |
| Decision | Substantially Equivalent, Mar 16, 1987 |
| Received | Oct 1, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K863843
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.