STC OPIATES MICRO-PLATE EIA (ORASURE APPLICATION)— 510(k) K981341

Name: FDA 510(k) clearance K981341
Creator: U.S. Food and Drug Administration
Published: 1998-05-22

Substantially Equivalent

OraSure Technologies, Inc.

FDA 510(k) clearance K981341 for STC OPIATES MICRO-PLATE EIA (ORASURE APPLICATION), Substantially Equivalent on 1998-05-22. Applicant: OraSure Technologies, Inc.. Device class: 2.

Clearance details

Applicant: OraSure Technologies, Inc.
Product code: Code DJG
Device class: Class 2
Regulation: 21 CFR 862.3650
Advisory panel: Clinical Toxicology
Date received: 1998-04-13
Decision date: 1998-05-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bethlehem, PA, US

Download summary PDF View on FDA.gov ↗

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