Cleared Traditional

UCP MULTI-DRUG TEST KEY CUPS

K132812 · Ucp Biosciences, Inc. · Toxicology
Mar 2014
Decision
178d
Days
Class 2
Risk

About This 510(k) Submission

K132812 is an FDA 510(k) clearance for the UCP MULTI-DRUG TEST KEY 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 March 6, 2014, 178 days after receiving the submission on September 9, 2013. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3100.

Submission Details

510(k) Number K132812 FDA.gov
FDA Decision Cleared SESE
Date Received September 09, 2013
Decision Date March 06, 2014
Days to Decision 178 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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