Cleared Traditional

UCP HOME DRUG SCREENING TEST; CARDS, CUPS

K130463 · Ucp Biosciences, Inc. · Toxicology
May 2013
Decision
82d
Days
Class 2
Risk

About This 510(k) Submission

K130463 is an FDA 510(k) clearance for the UCP HOME DRUG SCREENING TEST; CARDS, 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 May 15, 2013, 82 days after receiving the submission on February 22, 2013. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3100.

Submission Details

510(k) Number K130463 FDA.gov
FDA Decision Cleared SESE
Date Received February 22, 2013
Decision Date May 15, 2013
Days to Decision 82 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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