Cleared Special

CLEARBLUE EASY EARLY RESULT PREGNANCY TEST

K013372 · Unipath , Ltd. · Chemistry
Nov 2001
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K013372 is an FDA 510(k) clearance for the CLEARBLUE EASY EARLY RESULT PREGNANCY TEST, a Kit, Test, Pregnancy, Hcg, Over The Counter (Class II — Special Controls, product code LCX), submitted by Unipath , Ltd. (New York, US). The FDA issued a Cleared decision on November 9, 2001, 29 days after receiving the submission on October 11, 2001. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1155.

Submission Details

510(k) Number K013372 FDA.gov
FDA Decision Cleared SESE
Date Received October 11, 2001
Decision Date November 09, 2001
Days to Decision 29 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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