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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 K904782
Device Name ANSWER QUICK AND SIMPLE AT-HOME PREGNANCY TEST
Applicant
Carter Products
Half Acre Rd.
Cranbury,  NJ  08512
Applicant Contact STEPHEN KOLAKOWSKY
Correspondent
Carter Products
Half Acre Rd.
Cranbury,  NJ  08512
Correspondent Contact STEPHEN KOLAKOWSKY
Regulation Number862.1155
Classification Product Code
LCX  
Date Received10/22/1990
Decision Date 12/06/1990
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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