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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 K903019
Device Name MODIFIED COAG-1 PT TEST CARD
Applicant
Cardiovascular Diagnostic Services
P.O. Box 14025
2810 Meridian Pkwy. Suite 106
Research Triangle Park,  NC  27709
Applicant Contact SHARON DERMOTT
Correspondent
Cardiovascular Diagnostic Services
P.O. Box 14025
2810 Meridian Pkwy. Suite 106
Research Triangle Park,  NC  27709
Correspondent Contact SHARON DERMOTT
Regulation Number864.7750
Classification Product Code
GJS  
Date Received07/11/1990
Decision Date 08/01/1990
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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