Cleared Traditional

CLEARPLAN EASY HOME PREGNANCY TEST

K990262 · Unipath , Ltd. · Chemistry
Apr 1999
Decision
70d
Days
Class 2
Risk

About This 510(k) Submission

K990262 is an FDA 510(k) clearance for the CLEARPLAN EASY HOME 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 April 7, 1999, 70 days after receiving the submission on January 27, 1999. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1155.

Submission Details

510(k) Number K990262 FDA.gov
FDA Decision Cleared SESE
Date Received January 27, 1999
Decision Date April 07, 1999
Days to Decision 70 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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