Cleared Traditional

INSTANT-VIEW plus Multi-Drug of Abuse Urine Test - Simple Cup (OTC Use), INSTANT-VIEW plus Multi-Drug Urine Test - Simple Cup (Prescription Use)

K173303 · Alfa Scientific Designs, Inc. · Toxicology
Feb 2018
Decision
128d
Days
Class 2
Risk

About This 510(k) Submission

K173303 is an FDA 510(k) clearance for the INSTANT-VIEW plus Multi-Drug of Abuse Urine Test - Simple Cup (OTC Use), INSTANT-VIEW plus Multi-Drug Urine Test - Simple Cup (Prescription 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 February 23, 2018, 128 days after receiving the submission on October 18, 2017. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3100.

Submission Details

510(k) Number K173303 FDA.gov
FDA Decision Cleared SESE
Date Received October 18, 2017
Decision Date February 23, 2018
Days to Decision 128 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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