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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 K882444
Device Name COAG-I ANALYZER, ALPHA MODEL
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 Number864.5425
Classification Product Code
JPA  
Date Received06/14/1988
Decision Date 08/25/1988
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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