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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plasminogen, Antigen, Antiserum, Control
510(k) Number K854572
Device Name COATEST PLASMINOGEN
Applicant
Kabivitrum, Inc.
1311 Harbor Bay Pkwy.
Alameda,  CA  94501
Applicant Contact RONALD G LEONARDI
Correspondent
Kabivitrum, Inc.
1311 Harbor Bay Pkwy.
Alameda,  CA  94501
Correspondent Contact RONALD G LEONARDI
Regulation Number866.5715
Classification Product Code
DDX  
Date Received11/14/1985
Decision Date 02/26/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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