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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, Beta-2-Microglobulin Immunological
510(k) Number K946068
Device Name HUMAN BETA-2 MICROGLOBULIN ENHANCED RADIAL IMMUNODIFFUSION KIT
Applicant
The Binding Site, Ltd.
East Tower, Suite 600
2425 W. Olympic Blvd.
Santa Monica,  CA  90404
Applicant Contact JAY H GELLETR
Correspondent
The Binding Site, Ltd.
East Tower, Suite 600
2425 W. Olympic Blvd.
Santa Monica,  CA  90404
Correspondent Contact JAY H GELLETR
Regulation Number866.5630
Classification Product Code
JZG  
Date Received11/23/1994
Decision Date 01/30/1996
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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