AML HAIRCHECK-DT (COCAINE)— 510(k) K023626

Name: FDA 510(k) clearance K023626
Creator: U.S. Food and Drug Administration
Published: 2003-09-29

Substantially Equivalent

Quest Diagnostics, Inc.

FDA 510(k) clearance K023626 for AML HAIRCHECK-DT (COCAINE), Substantially Equivalent on 2003-09-29. Applicant: Quest Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Quest Diagnostics, Inc.
Product code: Code DIO
Device class: Class 2
Regulation: 21 CFR 862.3250
Advisory panel: Clinical Toxicology
Date received: 2002-10-29
Decision date: 2003-09-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Las Vegas, NV, US

Download summary PDF View on FDA.gov ↗

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