FDA 510(k) Application Details - K161854

Device Classification Name	More FDA Info for this Device
510(K) Number	K161854
Device Name	Hevylite Human IgG Kappa Kit for use on the SPAPLUS, Hevylite Human IgG Lambda Kit for use on the SPAPLUS
Applicant	THE BINDING SITE GROUP LTD 8 CALTHORPE ROAD EDGBASTON B15 1QT GB Other 510(k) Applications for this Company
Contact	ANDREA THOMAS Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PCN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/06/2016
Decision Date	10/04/2016
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