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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Multipurpose For In Vitro Coagulation Studies
510(k) Number K990566
Device Name TAS ANALYZER, MODEL 1009
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 Number864.5425
Classification Product Code
JPA  
Date Received02/22/1999
Decision Date 05/14/1999
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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