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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 K123436
Device Name FIRST RESPONSE EARLY RESULT PREGNANCY TEST
Applicant
CHURCH & DWIGHT CO., INC.
469 NORTH HARRISON STREET
PRINCETON,  NJ  08543
Applicant Contact JOSEPH CICCONE
Correspondent
CHURCH & DWIGHT CO., INC.
469 NORTH HARRISON STREET
PRINCETON,  NJ  08543
Correspondent Contact JOSEPH CICCONE
Regulation Number862.1155
Classification Product Code
LCX  
Date Received11/07/2012
Decision Date 08/26/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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