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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Igd, Antigen, Antiserum, Control
510(k) Number K051299
Device Name IGD DIAGNOSTIC TEST KITS
Applicant
The Binding Site, Ltd.
2425 W. Olympic Blvd.
West Tower Suite 4000
Santa Monica,  CA  90404
Applicant Contact JAY H GELLER
Correspondent
The Binding Site, Ltd.
2425 W. Olympic Blvd.
West Tower Suite 4000
Santa Monica,  CA  90404
Correspondent Contact JAY H GELLER
Regulation Number866.5510
Classification Product Code
CZJ  
Date Received05/18/2005
Decision Date 11/23/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Statement Statement
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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