Cleared Traditional

UCP COMPACT DRUG TESTS

K152908 · Ucp Biosciences, Inc. · Toxicology
May 2016
Decision
215d
Days
Class 2
Risk

About This 510(k) Submission

K152908 is an FDA 510(k) clearance for the UCP COMPACT DRUG TESTS, 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 May 3, 2016, 215 days after receiving the submission on October 1, 2015. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3100.

Submission Details

510(k) Number K152908 FDA.gov
FDA Decision Cleared SESE
Date Received October 01, 2015
Decision Date May 03, 2016
Days to Decision 215 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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