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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 K981178
Device Name THROMBOLYTIC ASSESSMENT SYSTEM LOW RANGE HEPARIN MANAGEMENT TEST CONTROLS
Applicant
CARDIOVASCULAR DIAGNOSTICS, INC.
5301 DEPARTURE DR.
RALEIGH,  NC  27616
Applicant Contact CYNTHIA PRITCHARD
Correspondent
CARDIOVASCULAR DIAGNOSTICS, INC.
5301 DEPARTURE DR.
RALEIGH,  NC  27616
Correspondent Contact CYNTHIA PRITCHARD
Regulation Number864.5425
Classification Product Code
GGN  
Date Received04/01/1998
Decision Date 04/27/1998
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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