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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Multipurpose For In Vitro Coagulation Studies
510(k) Number K914188
Device Name KOAGULAB CTS CHROMOGRNIC TESTING SYSTEM
Applicant
Ortho Diagnostic Systems, Inc.
1001 U.S. Highway 202
P.O Box 350
Raritan,  NJ  08869 -0606
Applicant Contact PATRICK A ROCHE
Correspondent
Ortho Diagnostic Systems, Inc.
1001 U.S. Highway 202
P.O Box 350
Raritan,  NJ  08869 -0606
Correspondent Contact PATRICK A ROCHE
Regulation Number864.5425
Classification Product Code
JPA  
Date Received09/18/1991
Decision Date 08/26/1992
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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