Cleared Special

E.P.T. CERTAINTY PREGNANCY TEST

K050930 · Unipath , Ltd. · Chemistry
May 2005
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K050930 is an FDA 510(k) clearance for the E.P.T. CERTAINTY 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 May 12, 2005, 28 days after receiving the submission on April 14, 2005. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1155.

Submission Details

510(k) Number K050930 FDA.gov
FDA Decision Cleared SESE
Date Received April 14, 2005
Decision Date May 12, 2005
Days to Decision 28 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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