510(k) K982759 ยท DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites
AUTO-LYTE COCAINE METABOLITE EIA, MODEL # 1222U
| Applicant | OraSure Technologies, Inc., Bethlehem PA, US |
| Decision | Substantially Equivalent, Nov 20, 1998 |
| Received | Aug 6, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K982759
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.