FDA 510(k) Application Details - K152389

Device Classification Name	More FDA Info for this Device
510(K) Number	K152389
Device Name	Optilite Hevylite IgM Kappa Kit; Optilite Hevylite IgM Lambda Kit
Applicant	THE BINDING SITE GROUP LTD 8 CALTHORPE RD EDGBASTON BIRMINGHAM B15 1QT GB Other 510(k) Applications for this Company
Contact	STEPHANIE THOULESS Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PDE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/24/2015
Decision Date	12/18/2015
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