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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
Original Applicant
THE BINDING SITE GROUP LTD
8 calthorpe road
edgbaston
birmingham, west midlands,  GB b15 1qt
Original 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
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