Cleared Traditional

VERDICT -II METHAMPHETAMINE

K010226 · Medtox Diagnostics, Inc. · Toxicology
Jun 2001
Decision
128d
Days
Class 2
Risk

About This 510(k) Submission

K010226 is an FDA 510(k) clearance for the VERDICT -II METHAMPHETAMINE, 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 June 1, 2001, 128 days after receiving the submission on January 24, 2001. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3610.

Submission Details

510(k) Number K010226 FDA.gov
FDA Decision Cleared SESE
Date Received January 24, 2001
Decision Date June 01, 2001
Days to Decision 128 days
Submission Type Traditional
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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