510(k) K001197 ยท DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites
COCAINE METABOLITE INTERCEPT MICRO-PLATE EIA
| Applicant | OraSure Technologies, Inc., Bethlehem PA, US |
| Decision | Substantially Equivalent, May 11, 2000 |
| Received | Apr 11, 2000 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K001197
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.