OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR COCAINE AND COCAINE METABOLITES— 510(k) K131128

Name: FDA 510(k) clearance K131128
Creator: U.S. Food and Drug Administration
Published: 2013-11-13

Substantially Equivalent

Omega Laboratories, Inc.

FDA 510(k) clearance K131128 for OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR COCAINE AND COCAINE METABOLITES, Substantially Equivalent on 2013-11-13. Applicant: Omega Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Omega Laboratories, Inc.
Product code: Code DIO
Device class: Class 2
Regulation: 21 CFR 862.3250
Advisory panel: Clinical Toxicology
Date received: 2013-04-23
Decision date: 2013-11-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mogadore, OH, US

Download summary PDF View on FDA.gov ↗

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