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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 K160070
Device Name Rheumatoid Factor (RF) Kit for use on SPAPLUS
Applicant
The Binding Site Group , Ltd.
8 Calthorpe Rd.
Edgbaston,  GB B15 1QT
Applicant Contact Jon Lauder
Correspondent
The Binding Site Group , Ltd.
8 Calthorpe Rd.
Edgbaston,  GB B15 1QT
Correspondent Contact Jon Lauder
Regulation Number866.5775
Classification Product Code
DHR  
Date Received01/13/2016
Decision Date 12/07/2016
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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