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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antithrombin Iii Quantitation
510(k) Number K902393
Device Name COACUTE ANTITHROMBIN CHROMOGENIC ASSAY
Applicant
Kabi Diagnostica
P.O. Box 430
Danville,  CA  94526
Applicant Contact G LEONARDI
Correspondent
Kabi Diagnostica
P.O. Box 430
Danville,  CA  94526
Correspondent Contact G LEONARDI
Regulation Number864.7060
Classification Product Code
JBQ  
Date Received05/30/1990
Decision Date 09/25/1990
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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