510(k) K982061 ยท DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites
STC COCAINE METABOLITE MICRO-PLATE EIA (ORASURE DEVICE)
| Applicant | OraSure Technologies, Inc., Bethlehem PA, US |
| Decision | Substantially Equivalent, Aug 25, 1998 |
| Received | Jun 4, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K982061
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 20, 2017 | OraSure Technologies, Inc. Cocaine Metabolite MICRO-PLATE EIA, Catalog Number: 1122SC, UDI: (0100608337000429(17)180228(10)000 Terminated |
DIO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.