Cleared Traditional

LIFESIGN HOME DRUG TEST (ECSTASY/MET), STATUS STIK MET & MDMA, ACCUSIGN STIK MET & MDMA, ACCUSTIK MET & MDMA

K023837 · Princeton BioMeditech Corp. · Toxicology
Sep 2003
Decision
301d
Days
Class 2
Risk

About This 510(k) Submission

K023837 is an FDA 510(k) clearance for the LIFESIGN HOME DRUG TEST (ECSTASY/MET), STATUS STIK MET & MDMA, ACCUSIGN STIK MET & MDMA, ACCUSTIK MET & MDMA, a Gas Chromatography, Methamphetamine (Class II — Special Controls, product code LAF), submitted by Princeton BioMeditech Corp. (Monmouth Junction, US). The FDA issued a Cleared decision on September 15, 2003, 301 days after receiving the submission on November 18, 2002. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3610.

Submission Details

510(k) Number K023837 FDA.gov
FDA Decision Cleared SESE
Date Received November 18, 2002
Decision Date September 15, 2003
Days to Decision 301 days
Submission Type Traditional
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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