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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Kit, Test, Pregnancy, Hcg, Over The Counter
510(k) Number K023699
Device Name CLEARBLUE EASY EARLY RESULT PREGNANCY TEST
Applicant
Unipath , Ltd.
Priory Business Park
Bedford,  GB MK44 3UP
Applicant Contact Louise Roberts
Correspondent
Unipath , Ltd.
Priory Business Park
Bedford,  GB MK44 3UP
Correspondent Contact Louise Roberts
Regulation Number862.1155
Classification Product Code
LCX  
Date Received11/04/2002
Decision Date 11/27/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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