FDA 510(k) Application Details - K151759

Device Classification Name	Immunoglobulin A Kappa Heavy & Light Chain Combined   More FDA Info for this Device
510(K) Number	K151759
Device Name	Immunoglobulin A Kappa Heavy & Light Chain Combined
Applicant	THE BINDING SITE GROUP LTD. 8 CALTROPE ROAD EDGBASTON B15 1QT GB Other 510(k) Applications for this Company
Contact	STEPHANIE THOULESS Other 510(k) Applications for this Contact
Regulation Number	866.5510   More FDA Info for this Regulation Number
Classification Product Code	OPX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/29/2015
Decision Date	11/06/2015
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