Cleared Special

CLEARBLUE EASY EASY READ PREGNANCY TEST

K041404 · Unipath , Ltd. · Chemistry
Jun 2004
Decision
13d
Days
Class 2
Risk

About This 510(k) Submission

K041404 is an FDA 510(k) clearance for the CLEARBLUE EASY EASY READ 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 June 8, 2004, 13 days after receiving the submission on May 26, 2004. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1155.

Submission Details

510(k) Number K041404 FDA.gov
FDA Decision Cleared SESE
Date Received May 26, 2004
Decision Date June 08, 2004
Days to Decision 13 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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