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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Visual, Pregnancy Hcg, Prescription Use
510(k) Number K872730
Device Name RESULT PLUS/HCG PREGNANCY TEST
Applicant
Ortho Diagnostic Systems, Inc.
1001 U.S. Hwy. 202
P.O Box 350
Raritan,  NJ  08869
Applicant Contact PATRICIA BONNESS
Correspondent
Ortho Diagnostic Systems, Inc.
1001 U.S. Hwy. 202
P.O Box 350
Raritan,  NJ  08869
Correspondent Contact PATRICIA BONNESS
Regulation Number862.1155
Classification Product Code
JHI  
Date Received07/08/1987
Decision Date 10/20/1987
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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