Cleared Special

E.P.T. CERTAINTY 1-STEP PREGNANCY TEST

K061769 · Unipath , Ltd. · Chemistry
Jul 2006
Decision
10d
Days
Class 2
Risk

About This 510(k) Submission

K061769 is an FDA 510(k) clearance for the E.P.T. CERTAINTY 1-STEP 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 July 3, 2006, 10 days after receiving the submission on June 23, 2006. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1155.

Submission Details

510(k) Number K061769 FDA.gov
FDA Decision Cleared SESE
Date Received June 23, 2006
Decision Date July 03, 2006
Days to Decision 10 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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