FDA 510(k) Application Details - K132555

Device Classification Name	More FDA Info for this Device
510(K) Number	K132555
Device Name	HEVYLITE HUMAN IGG KAPPA KIT AND HEVYLITE HUMAN IGG LAMBDA KIT
Applicant	THE BINDING SITE 8 Calthorpe Road Edgbaston BIRMINGHAM B15 1QT GB Other 510(k) Applications for this Company
Contact	Paul Kenny 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	08/14/2013
Decision Date	12/20/2013
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