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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 K896625
Device Name THROMBOPLASTIN, FOR USE IN PROTHROMBIN TIME DETER.
Applicant
MEDICAL DIAGNOSTIC TECHNOLOGIES, INC.
6020 NICOLLE ST., STE. D
VENTURA,  CA  93003
Applicant Contact BICK, PHD
Correspondent
MEDICAL DIAGNOSTIC TECHNOLOGIES, INC.
6020 NICOLLE ST., STE. D
VENTURA,  CA  93003
Correspondent Contact BICK, PHD
Regulation Number864.7750
Classification Product Code
GJS  
Date Received11/21/1989
Decision Date 12/11/1989
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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