Cleared Traditional

CLEARBLUE EASY DIGITAL PREGNANCY TEST

K060128 · Unipath , Ltd. · Chemistry
May 2006
Decision
127d
Days
Class 2
Risk

About This 510(k) Submission

K060128 is an FDA 510(k) clearance for the CLEARBLUE EASY DIGITAL 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 25, 2006, 127 days after receiving the submission on January 18, 2006. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1155.

Submission Details

510(k) Number K060128 FDA.gov
FDA Decision Cleared SESE
Date Received January 18, 2006
Decision Date May 25, 2006
Days to Decision 127 days
Submission Type Traditional
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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