Omega Laboratories Hair Drug Screening Assay Methamphetamine (Meth) and -3, 4-methylenedioxymethamphetamine (MDMA)— 510(k) K142855

Name: FDA 510(k) clearance K142855
Creator: U.S. Food and Drug Administration
Published: 2015-07-28

Substantially Equivalent

Omega Laboratories, Inc.

FDA 510(k) clearance K142855 for Omega Laboratories Hair Drug Screening Assay Methamphetamine (Meth) and -3, 4-methylenedioxymethamphetamine (MDMA), Substantially Equivalent on 2015-07-28. Applicant: Omega Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Omega Laboratories, Inc.
Product code: Code DKZ
Device class: Class 2
Regulation: 21 CFR 862.3100
Advisory panel: Clinical Toxicology
Date received: 2014-09-30
Decision date: 2015-07-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mogadore, OH, US

Download summary PDF View on FDA.gov ↗

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