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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 K120750
Device Name HUMAN IGM CSF KIT
Applicant
THE BINDING SITE GROUP LTD
8 CALTHORPE ROAD
EDGBASTON
BIRMINGHAM, WEST MIDLANDS,  GB B15 1QT
Applicant Contact JILL CONSTANTINE
Correspondent
THE BINDING SITE GROUP LTD
8 CALTHORPE ROAD
EDGBASTON
BIRMINGHAM, WEST MIDLANDS,  GB B15 1QT
Correspondent Contact JILL CONSTANTINE
Regulation Number866.5510
Classification Product Code
CFN  
Date Received03/12/2012
Decision Date 05/17/2013
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
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