STC COCAINE METABOLITE MICRO-PLATE EIA (ORASURE DEVICE)— 510(k) K982061

Substantially Equivalent

OraSure Technologies, Inc.

FDA 510(k) clearance K982061 for STC COCAINE METABOLITE MICRO-PLATE EIA (ORASURE DEVICE), Substantially Equivalent on 1998-08-25. Applicant: OraSure Technologies, Inc..

Clearance details

Applicant: OraSure Technologies, Inc.
Product code: Code DIO
Advisory panel: Clinical Toxicology
Date received: 1998-06-04
Decision date: 1998-08-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bethlehem, PA, US

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.