510(k) K001976 ยท DIS Enzyme Immunoassay, Barbiturate
STC BARBITURATES INTERCEPT MICRO-PLATE EIA, MODEL 1108I
| Applicant | OraSure Technologies, Inc., Bethlehem PA, US |
| Decision | Substantially Equivalent, Dec 6, 2000 |
| Received | Jun 29, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K001976
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 8, 2016 | OraSure Technologies, Inc. Barbiturates Intercept Micro-Plate EIA (enzyme immunoassay, barbiturate)
Product is intended for use by clinical laboratories in the qualitative determination of barbiturates in oral fluids. Terminated |
DIS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.