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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Analyzer, Heparin, Automated
510(k) Number K993519
Device Name RAPIDPOINT ACCENT, MODEL 2000, RAPIDPOINT COAG HEPARIN TITRATION TEST, RAPIDPOINT COAG PROTAMINE RESPONSE TEST
Applicant
CARDIOVASCULAR DIAGNOSTICS, INC.
5301 DEPARTURE DR.
RALEIGH,  NC  27616
Applicant Contact PETER SCOTT
Correspondent
CARDIOVASCULAR DIAGNOSTICS, INC.
5301 DEPARTURE DR.
RALEIGH,  NC  27616
Correspondent Contact PETER SCOTT
Regulation Number864.5680
Classification Product Code
JOX  
Date Received10/18/1999
Decision Date 01/14/2000
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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