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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Complement C1 Inhibitor (Inactivator), Antigen, Antiserum, Control
510(k) Number K915431
Device Name COMPLEMENT C1 INACTIVATOR KIT
Applicant
The Binding Site, Ltd.
Westside Towers, Suite 1000
11845 W. Olympic Blvd.
Los Angeles,  CA  90064
Applicant Contact JAY GELLER
Correspondent
The Binding Site, Ltd.
Westside Towers, Suite 1000
11845 W. Olympic Blvd.
Los Angeles,  CA  90064
Correspondent Contact JAY GELLER
Regulation Number866.5250
Classification Product Code
DBA  
Date Received12/02/1991
Decision Date 01/17/1992
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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