Cleared Special

E.P.T. PREGNANCY TEST

K033658 · Unipath , Ltd. · Chemistry
Jan 2004
Decision
56d
Days
Class 2
Risk

About This 510(k) Submission

K033658 is an FDA 510(k) clearance for the E.P.T. PREGNANCY TEST, a Kit, Test, Pregnancy, Hcg, Over The Counter (Class II — Special Controls, product code LCX), submitted by Unipath , Ltd. (Bedford, GB). The FDA issued a Cleared decision on January 16, 2004, 56 days after receiving the submission on November 21, 2003. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1155.

Submission Details

510(k) Number K033658 FDA.gov
FDA Decision Cleared SESE
Date Received November 21, 2003
Decision Date January 16, 2004
Days to Decision 56 days
Submission Type Special
Review Panel Chemistry (CH)
Summary Statement

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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