STC METHAMPHETAMINE MICRO-PLATE EIA— 510(k) K972989

Name: FDA 510(k) clearance K972989
Creator: U.S. Food and Drug Administration
Published: 1998-01-28

Substantially Equivalent

OraSure Technologies, Inc.

FDA 510(k) clearance K972989 for STC METHAMPHETAMINE MICRO-PLATE EIA, Substantially Equivalent on 1998-01-28. Applicant: OraSure Technologies, Inc.. Device class: 2.

Clearance details

Applicant: OraSure Technologies, Inc.
Product code: Code DKZ
Device class: Class 2
Regulation: 21 CFR 862.3100
Advisory panel: Clinical Toxicology
Date received: 1997-08-12
Decision date: 1998-01-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bethlehem, PA, US

Download summary PDF View on FDA.gov ↗

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