QUEST DIAGNOSTICS HAIRCHECK-DT (AMPHETAMINES)— 510(k) K051161

Name: FDA 510(k) clearance K051161
Creator: U.S. Food and Drug Administration
Published: 2005-11-22

Substantially Equivalent

Quest Diagnostics, Inc.

FDA 510(k) clearance K051161 for QUEST DIAGNOSTICS HAIRCHECK-DT (AMPHETAMINES), Substantially Equivalent on 2005-11-22. Applicant: Quest Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Quest Diagnostics, Inc.
Product code: Code DKZ
Device class: Class 2
Regulation: 21 CFR 862.3100
Advisory panel: Clinical Toxicology
Date received: 2005-05-05
Decision date: 2005-11-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Las Vegas, NV, US

Download summary PDF View on FDA.gov ↗

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