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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 K894420
Device Name ORTHO RESULT PLUS/PREGNANCY
Applicant
Ortho Diagnostic Systems, Inc.
1001 U.S. Hwy. 202
P.O Box 350
Raritan,  NJ  08869
Applicant Contact ANDREA CASPER
Correspondent
Ortho Diagnostic Systems, Inc.
1001 U.S. Hwy. 202
P.O Box 350
Raritan,  NJ  08869
Correspondent Contact ANDREA CASPER
Regulation Number862.1155
Classification Product Code
JHI  
Date Received07/17/1989
Decision Date 10/04/1989
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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