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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Assay, Heparin
510(k) Number K901874
Device Name COATEST LMW HEPARIN/HEPARIN CHROMOGENIC ASSAY
Applicant
Kabi Diagnostica
P.O. Box 430
Danville,  CA  94526
Applicant Contact LEONARDI, PHD
Correspondent
Kabi Diagnostica
P.O. Box 430
Danville,  CA  94526
Correspondent Contact LEONARDI, PHD
Regulation Number864.7525
Classification Product Code
KFF  
Date Received04/26/1990
Decision Date 07/20/1990
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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