Cleared Special

UCP Drug Test Mini Cups

K151213 · Ucp Biosciences, Inc. · Toxicology
Aug 2015
Decision
107d
Days
Class 2
Risk

About This 510(k) Submission

K151213 is an FDA 510(k) clearance for the UCP Drug Test Mini 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 August 21, 2015, 107 days after receiving the submission on May 6, 2015. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3100.

Submission Details

510(k) Number K151213 FDA.gov
FDA Decision Cleared SESE
Date Received May 06, 2015
Decision Date August 21, 2015
Days to Decision 107 days
Submission Type Special
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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