Cleared Special

EPT CERTAINTY PREGNANCY TEST

K032939 · Unipath , Ltd. · Chemistry
Oct 2003
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K032939 is an FDA 510(k) clearance for the EPT 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 October 20, 2003, 28 days after receiving the submission on September 22, 2003. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1155.

Submission Details

510(k) Number K032939 FDA.gov
FDA Decision Cleared SESE
Date Received September 22, 2003
Decision Date October 20, 2003
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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