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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 K122066
Device Name HUMAN BETA-2 MICROGLOBULIN URINE KIT FOR USE ON THE SPAPLUS
Applicant
The Binding Site Group , Ltd.
8 Calthorpe Rd.
Birmingham,  GB B15 1QT
Applicant Contact JILL CONSTANTINE
Correspondent
The Binding Site Group , Ltd.
8 Calthorpe Rd.
Birmingham,  GB B15 1QT
Correspondent Contact JILL CONSTANTINE
Regulation Number866.5630
Classification Product Code
JZG  
Date Received07/16/2012
Decision Date 08/30/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Statement Statement
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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