AUTO-LYTE COTININE EIA— 510(k) K972481

Name: FDA 510(k) clearance K972481
Creator: U.S. Food and Drug Administration
Published: 1997-10-21

Substantially Equivalent

OraSure Technologies, Inc.

FDA 510(k) clearance K972481 for AUTO-LYTE COTININE EIA, Substantially Equivalent on 1997-10-21. Applicant: OraSure Technologies, Inc.. Device class: 1.

Clearance details

Applicant: OraSure Technologies, Inc.
Product code: Code MKU
Device class: Class 1
Regulation: 21 CFR 862.3220
Advisory panel: Clinical Toxicology
Date received: 1997-07-02
Decision date: 1997-10-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bethlehem, PA, US

Download summary PDF View on FDA.gov ↗

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