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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Igg (Fc Fragment Specific), Antigen, Antiserum, Control
510(k) Number K895600
Device Name HUMAN (IGG) SUBCLASS (EIA) KIT
Applicant
The Binding Site, Ltd.
Westside Towers, Suite 1000
11845 W. Olympic Blvd.
Los Angeles,  CA  90064
Applicant Contact JAY H GELLER
Correspondent
The Binding Site, Ltd.
Westside Towers, Suite 1000
11845 W. Olympic Blvd.
Los Angeles,  CA  90064
Correspondent Contact JAY H GELLER
Regulation Number866.5530
Classification Product Code
DAS  
Date Received09/18/1989
Decision Date 11/08/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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