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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Luteinizing Hormone
510(k) Number K853142
Device Name OVUTIME OVULATION PREDICTOR TEST
Applicant
Advanced Care Products
Div. Of Ortho Pharmaceutical
Raritan,  NJ  08869
Applicant Contact JEAN GRIERE
Correspondent
Advanced Care Products
Div. Of Ortho Pharmaceutical
Raritan,  NJ  08869
Correspondent Contact JEAN GRIERE
Regulation Number862.1485
Classification Product Code
CEP  
Date Received07/29/1985
Decision Date 12/17/1985
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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