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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Test, Anticardiolipin Immunological
510(k) Number K032240
Device Name BINDAZYME HUMAN ANTI-PHOSPHATIDYLSERINE IGA, IGG AND IGM ENZYME IMMUNOASSAY KIT
Applicant
The Binding Site, Ltd.
West Tower, Suite 4000
2425 W. Olympic Blvd.
Santa Monica,  CA  90404
Applicant Contact JAY H GELLER
Correspondent
The Binding Site, Ltd.
West Tower, Suite 4000
2425 W. Olympic Blvd.
Santa Monica,  CA  90404
Correspondent Contact JAY H GELLER
Regulation Number866.5660
Classification Product Code
MID  
Date Received07/21/2003
Decision Date 09/29/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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