510(k) K013882 ยท JXM Enzyme Immunoassay, Benzodiazepine
OTI BENZODIAZEPINES INTERCEPT MICRO-PLATE EIA MODEL #1110I
| Applicant | OraSure Technologies, Inc., Bethlehem PA, US |
| Decision | Substantially Equivalent, Apr 17, 2002 |
| Received | Nov 23, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K013882
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 13, 2020 | OraSure Technologies, Inc. Orasure Technologies Interept Benzodiazopene Miro-Plate EIA-Benzo EIA 5plate Matrix Oral Fluid Coated Micro-Plate-IVD Immunoassay for Benzodiazepines, Product Number: 1110IB Terminated |
JXM | None listed |
| Jul 13, 2020 | OraSure Technologies, Inc. Orasure Technologies Interept Benzodiazopene Miro-Plate EIA-Benzo EIA 2 plate Matrix Oral Fluid Coated Micro-Plate. IVD Immunoassay for Benzodiazepines, Product Number: 1110IT Terminated |
JXM | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.