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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, rheumatoid factor
510(k) Number K162263
Device Name Optilite Rheumatoid Factor Kit
Applicant
THE BINDING SITE GROUP LTD.
8 CALTHORPE ROAD
EDGBASTON
BIRMINGHAM,  GB B15 1QT
Applicant Contact JON LAUDER
Correspondent
THE BINDING SITE GROUP LTD.
8 CALTHORPE ROAD
EDGBASTON
BIRMINGHAM,  GB B15 1QT
Correspondent Contact JON LAUDER
Regulation Number866.5775
Classification Product Code
DHR  
Date Received08/11/2016
Decision Date 05/03/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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