FDA 510(k) Application Details - K140686

Device Classification Name	More FDA Info for this Device
510(K) Number	K140686
Device Name	HEVYLITE HUMAN IGM KAPPA AND LAMBDA KIT FOR USE ON SPAPLUS
Applicant	THE BINDING SITE GROUP LTD 8 CALTHORPE ROAD EDGBASTON BIRMINGHAM, WEST MIDLANDS B15 1QT GB Other 510(k) Applications for this Company
Contact	SUZANNE HORNE 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	03/19/2014
Decision Date	08/06/2014
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	IM - Immunology
Review Advisory Committee	IM - Immunology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review