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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 K914990
Device Name ADVANCE(R) PREGNANCY TEST
Applicant
Ortho Pharmaceutical Corp.
Rte. 202, P.O. Box 300
Raritan,  NJ  08869
Applicant Contact MARYLOU PANICO
Correspondent
Ortho Pharmaceutical Corp.
Rte. 202, P.O. Box 300
Raritan,  NJ  08869
Correspondent Contact MARYLOU PANICO
Regulation Number862.1155
Classification Product Code
LCX  
Date Received11/07/1991
Decision Date 12/23/1991
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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