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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Test, Time, Prothrombin
510(k) Number K904325
Device Name COAG-1 PT-NC TEST CARD
Applicant
Cardiovascular Diagnostic Services
P.O. Box 14025
2810 Meridian Pkwy. Suite 106
Research Triangle Park,  NC  27709
Applicant Contact SHARON C DERMOTT
Correspondent
Cardiovascular Diagnostic Services
P.O. Box 14025
2810 Meridian Pkwy. Suite 106
Research Triangle Park,  NC  27709
Correspondent Contact SHARON C DERMOTT
Regulation Number864.7750
Classification Product Code
GJS  
Date Received09/20/1990
Decision Date 01/25/1991
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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