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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 K900782
Device Name HEPARIN CONTROL PLASMA, FOR USE IN APTT
Applicant
Medical Diagnostic Technologies, Inc.
6020 Nicolle St., Suite D
Ventura,  CA  93003
Applicant Contact BICK, PHD
Correspondent
Medical Diagnostic Technologies, Inc.
6020 Nicolle St., Suite D
Ventura,  CA  93003
Correspondent Contact BICK, PHD
Regulation Number864.5425
Classification Product Code
GGC  
Date Received02/20/1990
Decision Date 03/27/1990
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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