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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Method, Nephelometric, Immunoglobulins (G, A, M)
510(k) Number K150526
Device Name Optilite IgG4 Kit
Applicant
THE BINDING SITE GROUP LTD
8 CALTHORPE ROAD
EDGBASTON
BIRMINGHAM, WEST MIDLANDS,  GB B15 1QT
Applicant Contact Andrea Thomas
Correspondent
THE BINDING SITE GROUP LTD
8 CALTHORPE ROAD
EDGBASTON
BIRMINGHAM, WEST MIDLANDS,  GB B15 1QT
Correspondent Contact Andrea Thomas
Regulation Number866.5510
Classification Product Code
CFN  
Date Received03/02/2015
Decision Date 05/30/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Statement Statement
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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