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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Coagulation, Automated
510(k) Number K933092
Device Name TAS ANALYZER
Applicant
Cardiovascular Diagnostic Services
2810 Meridian Pkwy.
Suite 106
Durham,  NC  27713
Applicant Contact SHARON DERMOTT
Correspondent
Cardiovascular Diagnostic Services
2810 Meridian Pkwy.
Suite 106
Durham,  NC  27713
Correspondent Contact SHARON DERMOTT
Regulation Number864.5400
Classification Product Code
GKP  
Date Received06/24/1993
Decision Date 11/15/1993
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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