Cleared Special

AT WORK DRUG TEST, MODEL 9147T AWT

K010836 · Phamatech · Toxicology
Apr 2001
Decision
22d
Days
Class 2
Risk

About This 510(k) Submission

K010836 is an FDA 510(k) clearance for the AT WORK DRUG TEST, MODEL 9147T AWT, a Gas Chromatography, Methamphetamine (Class II — Special Controls, product code LAF), submitted by Phamatech (San Diego, US). The FDA issued a Cleared decision on April 11, 2001, 22 days after receiving the submission on March 20, 2001. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3610.

Submission Details

510(k) Number K010836 FDA.gov
FDA Decision Cleared SESE
Date Received March 20, 2001
Decision Date April 11, 2001
Days to Decision 22 days
Submission Type Special
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code LAF — Gas Chromatography, Methamphetamine
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3610

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