AUTO-LYTE COCAINE METABOLITE EIA, MODEL # 1222U— 510(k) K982759

Substantially Equivalent

OraSure Technologies, Inc.

FDA 510(k) clearance K982759 for AUTO-LYTE COCAINE METABOLITE EIA, MODEL # 1222U, Substantially Equivalent on 1998-11-20. Applicant: OraSure Technologies, Inc..

Clearance details

Applicant: OraSure Technologies, Inc.
Product code: Code DIO
Advisory panel: Clinical Toxicology
Date received: 1998-08-06
Decision date: 1998-11-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bethlehem, PA, US

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