Cleared Special

VERDICT-II

K022141 · Medtox Diagnostics, Inc. · Toxicology
Jul 2002
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K022141 is an FDA 510(k) clearance for the VERDICT-II, a Thin Layer Chromatography, Methamphetamine (Class II — Special Controls, product code DJC), submitted by Medtox Diagnostics, Inc. (Burlington, US). The FDA issued a Cleared decision on July 30, 2002, 28 days after receiving the submission on July 2, 2002. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3610.

Submission Details

510(k) Number K022141 FDA.gov
FDA Decision Cleared SESE
Date Received July 02, 2002
Decision Date July 30, 2002
Days to Decision 28 days
Submission Type Special
Review Panel Toxicology (TX)
Summary Statement

Device Classification

Product Code DJC — Thin Layer Chromatography, Methamphetamine
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3610

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