510(k) K993208 ยท LAF Gas Chromatography, Methamphetamine
STC METHAMPHETAMINE INTERCEPT MICRO-PLATE EIA, MODEL 1104I
| Applicant | OraSure Technologies, Inc., Bethlehem PA, US |
| Decision | Substantially Equivalent, Apr 3, 2000 |
| Received | Sep 24, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K993208
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 5, 2021 | OraSure Technologies, Inc. Methamphetamine Intercept Microplate kit EIA - IVD qualitative determination of methamphetamine in oral fluid, PN 11041C. Terminated |
LAF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.