Quest Diagnostics HairCheck-DT (Cocaine)— 510(k) K152232

Name: FDA 510(k) clearance K152232
Creator: U.S. Food and Drug Administration
Published: 2016-11-18

Substantially Equivalent

Quest Diagnostics Incorporated

FDA 510(k) clearance K152232 for Quest Diagnostics HairCheck-DT (Cocaine), Substantially Equivalent on 2016-11-18. Applicant: Quest Diagnostics Incorporated. Device class: 2.

Clearance details

Applicant: Quest Diagnostics Incorporated
Product code: Code DIO
Device class: Class 2
Regulation: 21 CFR 862.3250
Advisory panel: Clinical Toxicology
Date received: 2015-08-07
Decision date: 2016-11-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lenexa, KS, US

Download summary PDF View on FDA.gov ↗

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