Cleared Special

QUICKSCREEN METHAMPHETAMINE TEST, MODELS 9045, 9046, QUICKSCREEN PRO MULTI DRUG SCREENING TEST, MODEL 9225

K000447 · Phamatech · Toxicology
Mar 2000
Decision
26d
Days
Class 2
Risk

About This 510(k) Submission

K000447 is an FDA 510(k) clearance for the QUICKSCREEN METHAMPHETAMINE TEST, MODELS 9045, 9046, QUICKSCREEN PRO MULTI DRUG SCREENING TEST, MODEL 9225, a Gas Chromatography, Methamphetamine (Class II — Special Controls, product code LAF), submitted by Phamatech (San Diego, US). The FDA issued a Cleared decision on March 7, 2000, 26 days after receiving the submission on February 10, 2000. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3610.

Submission Details

510(k) Number K000447 FDA.gov
FDA Decision Cleared SESE
Date Received February 10, 2000
Decision Date March 07, 2000
Days to Decision 26 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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