510(k) K002375 ยท LDJ Enzyme Immunoassay, Cannabinoids
STC CANNABINOIDS INTERCEPT MICRO-PLATE EIA, MODEL 1118I
| Applicant | OraSure Technologies, Inc., Bethlehem PA, US |
| Decision | Substantially Equivalent, Jan 26, 2001 |
| Received | Aug 4, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K002375
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 23, 2008 | OraSure Technologies, Inc. Micro Plate EIA Oral Fluid Positive Control which is a component of the Intercept Micro Plate EIA kit. Terminated |
LDJ | None listed |
| Dec 23, 2008 | OraSure Technologies, Inc. Micro Plate EIA Oral Fluid Negative Control which is a component of the Intercept Micro Plate EIA kit. Terminated |
LDJ | None listed |
| Dec 23, 2008 | OraSure Technologies, Inc. Micro Plate EIA Oral Fluid Cutoff Calibrator which is a component of the Intercept Micro Plate EIA kit. Terminated |
LDJ | None listed |
| Dec 18, 2008 | OraSure Technologies, Inc. Cannabinoids Intercept Micro Plate EIA 100 plate kit Terminated |
LDJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.