Cleared Special

MODIFICATION TO E.P.T. PREGNANCY TEST

K040329 · Unipath , Ltd. · Chemistry
Mar 2004
Decision
26d
Days
Class 2
Risk

About This 510(k) Submission

K040329 is an FDA 510(k) clearance for the MODIFICATION TO 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 March 8, 2004, 26 days after receiving the submission on February 11, 2004. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1155.

Submission Details

510(k) Number K040329 FDA.gov
FDA Decision Cleared SESE
Date Received February 11, 2004
Decision Date March 08, 2004
Days to Decision 26 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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