Cleared Traditional

Instant-View Multi-Drug Urine Test Cup (Home Use), Instant-View Multi-Drug Urine Test Panel (Home Use)

K152122 · Alfa Scientific Designs, Inc. · Toxicology
Jun 2016
Decision
330d
Days
Class 2
Risk

About This 510(k) Submission

K152122 is an FDA 510(k) clearance for the Instant-View Multi-Drug Urine Test Cup (Home Use), Instant-View Multi-Drug Urine Test Panel (Home Use), a Enzyme Immunoassay, Amphetamine (Class II — Special Controls, product code DKZ), submitted by Alfa Scientific Designs, Inc. (Poway, US). The FDA issued a Cleared decision on June 24, 2016, 330 days after receiving the submission on July 30, 2015. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3100.

Submission Details

510(k) Number K152122 FDA.gov
FDA Decision Cleared SESE
Date Received July 30, 2015
Decision Date June 24, 2016
Days to Decision 330 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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