510(k) K973651 ยท DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites
STC COCAINE METABOLITE MICRO-PLATE EIA
| Applicant | OraSure Technologies, Inc., Bethlehem PA, US |
| Decision | Substantially Equivalent, Jan 2, 1998 |
| Received | Sep 25, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K973651
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.