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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 K880472
Device Name ADVANCE* AND DAISY* PREGNANCY TEST
Applicant
Advanced Care Products
Div. Of Ortho Pharmaceutical
Raritan,  NJ  08869
Applicant Contact JEAN R GRIEVE
Correspondent
Advanced Care Products
Div. Of Ortho Pharmaceutical
Raritan,  NJ  08869
Correspondent Contact JEAN R GRIEVE
Regulation Number862.1155
Classification Product Code
LCX  
Date Received02/04/1988
Decision Date 05/16/1988
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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