Cleared Traditional

UCP PREGNANCY CASSETTE TEST, DIP/CARD STRIP, HOME PREGNANCY CASSETTE TEST, MIDSTREAM TEST AND DIP/CARD STRIP

K131236 · Ucp Biosciences, Inc. · Chemistry
Nov 2013
Decision
190d
Days
Class 2
Risk

About This 510(k) Submission

K131236 is an FDA 510(k) clearance for the UCP PREGNANCY CASSETTE TEST, DIP/CARD STRIP, HOME PREGNANCY CASSETTE TEST, MIDSTREAM TEST AND DIP/CARD STRIP, a Kit, Test, Pregnancy, Hcg, Over The Counter (Class II — Special Controls, product code LCX), submitted by Ucp Biosciences, Inc. (San Jose, US). The FDA issued a Cleared decision on November 7, 2013, 190 days after receiving the submission on May 1, 2013. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1155.

Submission Details

510(k) Number K131236 FDA.gov
FDA Decision Cleared SESE
Date Received May 01, 2013
Decision Date November 07, 2013
Days to Decision 190 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code LCX — Kit, Test, Pregnancy, Hcg, Over The Counter
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1155

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