Cleared Special

VERDICT II THC/COC/OPI/AMP, VERDICTII THC/COC/OPI,VERDICT II THC/COC/AMP,VERDICT II THC/COC/PCP,VERDICT II THC/COC

K003687 · Medtox Diagnostics, Inc. · Toxicology
Dec 2000
Decision
22d
Days
Class 2
Risk

About This 510(k) Submission

K003687 is an FDA 510(k) clearance for the VERDICT II THC/COC/OPI/AMP, VERDICTII THC/COC/OPI,VERDICT II THC/COC/AMP,VERDICT II THC/COC/PCP,VERDICT II THC/COC, a Reagents, Test, Tetrahydrocannabinol (Class II — Special Controls, product code DKE), submitted by Medtox Diagnostics, Inc. (Burlington, US). The FDA issued a Cleared decision on December 22, 2000, 22 days after receiving the submission on November 30, 2000. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3870.

Submission Details

510(k) Number K003687 FDA.gov
FDA Decision Cleared SESE
Date Received November 30, 2000
Decision Date December 22, 2000
Days to Decision 22 days
Submission Type Special
Review Panel Toxicology (TX)
Summary Statement

Device Classification

Product Code DKE — Reagents, Test, Tetrahydrocannabinol
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3870

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