Cleared Special

UCP COMPACT DRUG TEST CARDS, UCP COMPACT DRUG TEST CUPS

K131811 · Ucp Biosciences, Inc. · Toxicology
Jul 2013
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K131811 is an FDA 510(k) clearance for the UCP COMPACT DRUG TEST CARDS, UCP COMPACT DRUG TEST CUPS, a Enzyme Immunoassay, Amphetamine (Class II — Special Controls, product code DKZ), submitted by Ucp Biosciences, Inc. (San Jose, US). The FDA issued a Cleared decision on July 19, 2013, 30 days after receiving the submission on June 19, 2013. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3100.

Submission Details

510(k) Number K131811 FDA.gov
FDA Decision Cleared SESE
Date Received June 19, 2013
Decision Date July 19, 2013
Days to Decision 30 days
Submission Type Special
Review Panel Toxicology (TX)
Summary Statement

Device Classification

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

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