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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 K960436
Device Name SELFCARE EARLY PREGNANCY TEST
Applicant
SELFCARE, INC.
MERVUE INDUSTRIAL ESTATE
GALWAY,  IE
Applicant Contact KATHLEEN M CLOUGH
Correspondent
SELFCARE, INC.
MERVUE INDUSTRIAL ESTATE
GALWAY,  IE
Correspondent Contact KATHLEEN M CLOUGH
Regulation Number862.1155
Classification Product Code
LCX  
Date Received01/31/1996
Decision Date 03/19/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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