FDA 510(k) Application Details - K160070

Device Classification Name	System, Test, Rheumatoid Factor   More FDA Info for this Device
510(K) Number	K160070
Device Name	System, Test, Rheumatoid Factor
Applicant	THE BINDING SITE GROUP, LTD. 8 CALTHORPE ROAD EDGBASTON B15 1QT GB Other 510(k) Applications for this Company
Contact	Jon Lauder Other 510(k) Applications for this Contact
Regulation Number	866.5775   More FDA Info for this Regulation Number
Classification Product Code	DHR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/13/2016
Decision Date	12/07/2016
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	IM - Immunology
Review Advisory Committee	IM - Immunology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review