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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K852834
Device Name ORTHO HEMATOLOGY CONT 14 NORMAL, 14 ABNORMAL H & L
Applicant
Ortho Diagnostic Systems, Inc.
1001 U.S. Highway 202
P.O Box 350
Raritan,  NJ  08869 -0606
Applicant Contact PATRICIA BONNESS
Correspondent
Ortho Diagnostic Systems, Inc.
1001 U.S. Highway 202
P.O Box 350
Raritan,  NJ  08869 -0606
Correspondent Contact PATRICIA BONNESS
Date Received07/02/1985
Decision Date 08/08/1985
Decision Substantially Equivalent (SESE)
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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