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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plasma, Control, Normal
510(k) Number K961814
Device Name THROMBOLYTIC ASSESSMENT SYSTEM PROTHROMBIN TIME TEST CONTROLS
Applicant
Cardiovascular Diagnostics, Inc.
5301 Departure Dr.
Raleigh,  NC  27616
Applicant Contact James M Clinton
Correspondent
Cardiovascular Diagnostics, Inc.
5301 Departure Dr.
Raleigh,  NC  27616
Correspondent Contact James M Clinton
Regulation Number864.5425
Classification Product Code
GIZ  
Subsequent Product Codes
GGC   GGN   GJS  
Date Received05/10/1996
Decision Date 08/13/1996
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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