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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plasma, Coagulation Control
510(k) Number K902210
Device Name ORTHOKROME NORMAL AND ABNORMAL CONTROL PLASMA
Applicant
Ortho Diagnostic Systems, Inc.
1001 U.S. Hwy. 202
P.O Box 350
Raritan,  NJ  08869
Applicant Contact PATRICK A ROCHE,PHD
Correspondent
Ortho Diagnostic Systems, Inc.
1001 U.S. Hwy. 202
P.O Box 350
Raritan,  NJ  08869
Correspondent Contact PATRICK A ROCHE,PHD
Regulation Number864.5425
Classification Product Code
GGN  
Date Received05/16/1990
Decision Date 07/03/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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