Cleared Traditional

K171695 - 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 (FDA 510(k) Clearance)

K171695 · W.H.P.M., Inc. · Toxicology device

Feb 2018

Decision

243d

Days

Class 2

Risk

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. This device is classified as 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 FDA review panel. Regulated under 21 CFR 862.3100.

Submission Details

510(k) Number	K171695 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (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