Cleared Traditional

QUICKSCREEN AMPHETINE 500 TEST

K131069 · Phamatech, Inc. · Toxicology
May 2014
Decision
392d
Days
Class 2
Risk

About This 510(k) Submission

K131069 is an FDA 510(k) clearance for the QUICKSCREEN AMPHETINE 500 TEST, a Enzyme Immunoassay, Amphetamine (Class II — Special Controls, product code DKZ), submitted by Phamatech, Inc. (San Diego, US). The FDA issued a Cleared decision on May 14, 2014, 392 days after receiving the submission on April 17, 2013. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3100.

Submission Details

510(k) Number K131069 FDA.gov
FDA Decision Cleared SESE
Date Received April 17, 2013
Decision Date May 14, 2014
Days to Decision 392 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code DKZ — Enzyme Immunoassay, Amphetamine
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3100

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