Cleared Traditional

CLEARBLUE EASY DIGITAL PREGNANCY TEST

K030659 · Unipath , Ltd. · Chemistry
May 2003
Decision
60d
Days
Class 2
Risk

About This 510(k) Submission

K030659 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 2, 2003, 60 days after receiving the submission on March 3, 2003. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1155.

Submission Details

510(k) Number K030659 FDA.gov
FDA Decision Cleared SESE
Date Received March 03, 2003
Decision Date May 02, 2003
Days to Decision 60 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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