Cleared Traditional

OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY CARDOXY-THC (THCA)

K122759 · Omega Laboratories, Inc. · Toxicology
Dec 2012
Decision
86d
Days
Class 2
Risk

About This 510(k) Submission

K122759 is an FDA 510(k) clearance for the OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY CARDOXY-THC (THCA), a Enzyme Immunoassay, Cannabinoids (Class II — Special Controls, product code LDJ), submitted by Omega Laboratories, Inc. (Mogadore, US). The FDA issued a Cleared decision on December 5, 2012, 86 days after receiving the submission on September 10, 2012. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3870.

Submission Details

510(k) Number K122759 FDA.gov
FDA Decision Cleared SESE
Date Received September 10, 2012
Decision Date December 05, 2012
Days to Decision 86 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code LDJ — Enzyme Immunoassay, Cannabinoids
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3870

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