OTI BENZODIAZEPINES INTERCEPT MICRO-PLATE EIA MODEL #1110I— 510(k) K013882
Substantially EquivalentOraSure Technologies, Inc.
FDA 510(k) clearance K013882 for OTI BENZODIAZEPINES INTERCEPT MICRO-PLATE EIA MODEL #1110I, Substantially Equivalent on 2002-04-17. Applicant: OraSure Technologies, Inc.. Device class: 2.
Clearance details
- Applicant
- OraSure Technologies, Inc.
- Product code
- Code JXM
- Device class
- Class 2
- Regulation
- 21 CFR 862.3170
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bethlehem, PA, US
Recent devices under product code JXM
view allMore clearances from OraSure Technologies, Inc.
view allRecalls naming K013882
K-number listed on FDA's recall record- Z-2876-2020 — Orasure Technologies Interept Benzodiazopene Miro-Plate EIA-Benzo EIA 5plate Matrix Oral Fluid Coated Micro-Plate-IVD Immunoassay for Benzodiazepines, Product Number: 1110IB
- Z-2877-2020 — Orasure Technologies Interept Benzodiazopene Miro-Plate EIA-Benzo EIA 2 plate Matrix Oral Fluid Coated Micro-Plate. IVD Immunoassay for Benzodiazepines, Product Number: 1110IT
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K013882.
Data sourced from openFDA. This site is unofficial and independent of the FDA.