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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 K843535
Device Name ORTHO BRAIN THROMBOPLASTIN DILUENT
Applicant
Ortho Diagnostic Systems, Inc.
125 Mark Ave.
Carpinteria,  CA  93013
Applicant Contact PATRICIA BONNESS
Correspondent
Ortho Diagnostic Systems, Inc.
125 Mark Ave.
Carpinteria,  CA  93013
Correspondent Contact PATRICIA BONNESS
Regulation Number864.7750
Classification Product Code
GJS  
Date Received09/07/1984
Decision Date 12/12/1984
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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