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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Control, Plasma, Abnormal
510(k) Number K901233
Device Name ORTHO ABNORMAL PROTEIN C CONTROL PLASMA
Applicant
Ortho Diagnostic Systems, Inc.
1001 U.S. Hwy. 202
P.O Box 350
Raritan,  NJ  08869
Applicant Contact ROCHE, PHD
Correspondent
Ortho Diagnostic Systems, Inc.
1001 U.S. Hwy. 202
P.O Box 350
Raritan,  NJ  08869
Correspondent Contact ROCHE, PHD
Regulation Number864.5425
Classification Product Code
GGC  
Date Received03/14/1990
Decision Date 04/11/1990
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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