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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Test, Time, Prothrombin
510(k) Number K935748
Device Name ORTHO RECOMBIPLASTIN II W/ORTHO RECOMBIPLASTIN II DILUENT
Applicant
Ortho Diagnostic Systems, Inc.
1001 U.S. Hwy. 202
P.O Box 350
Raritan,  NJ  08869
Applicant Contact PATRICK A ROCHE, PH.D
Correspondent
Ortho Diagnostic Systems, Inc.
1001 U.S. Hwy. 202
P.O Box 350
Raritan,  NJ  08869
Correspondent Contact PATRICK A ROCHE, PH.D
Regulation Number864.7750
Classification Product Code
GJS  
Date Received12/01/1993
Decision Date 04/26/1995
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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