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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plasma, Coagulation Control
510(k) Number K961189
Device Name TAS A PTT 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
GGN  
Date Received03/26/1996
Decision Date 06/05/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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