Cleared Traditional

First Sign Drug of Abuse Dip Card Test, First Sign Drug of Abuse Cup Test

K150162 · W.H.P.M., Inc. · Chemistry
Feb 2015
Decision
31d
Days
Class 2
Risk

About This 510(k) Submission

K150162 is an FDA 510(k) clearance for the First Sign Drug of Abuse Dip Card Test, First Sign Drug of Abuse Cup Test, a Gas Chromatography, Methamphetamine (Class II — Special Controls, product code LAF), submitted by W.H.P.M., Inc. (Irwindale, US). The FDA issued a Cleared decision on February 26, 2015, 31 days after receiving the submission on January 26, 2015. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.3610.

Submission Details

510(k) Number K150162 FDA.gov
FDA Decision Cleared SESE
Date Received January 26, 2015
Decision Date February 26, 2015
Days to Decision 31 days
Submission Type Traditional
Review Panel Chemistry (CH)
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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