Cleared Traditional

First Sign Multi-Drug Dip Card Test, First Sign Multi-Drug Cup Test, First Sign Drug of Abuse Dip Card Test Marijuana, First Sign Drug of Abuse Cup Test Marijuana

K171695 · W.H.P.M., Inc. · Toxicology
Feb 2018
Decision
243d
Days
Class 2
Risk

About This 510(k) Submission

K171695 is an FDA 510(k) clearance for the First Sign Multi-Drug Dip Card Test, First Sign Multi-Drug Cup Test, First Sign Drug of Abuse Dip Card Test Marijuana, First Sign Drug of Abuse Cup Test Marijuana, a Test, Amphetamine, Over The Counter (Class II — Special Controls, product code NFT), submitted by W.H.P.M., Inc. (Irwindale, US). The FDA issued a Cleared decision on February 5, 2018, 243 days after receiving the submission on June 7, 2017. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3100.

Submission Details

510(k) Number K171695 FDA.gov
FDA Decision Cleared SESE
Date Received June 07, 2017
Decision Date February 05, 2018
Days to Decision 243 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code NFT — Test, Amphetamine, Over The Counter
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3100

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