FDA 510(k) Applications for Medical Device Product Code: PDE ()

FDA 510(k) Applications for Medical Device Product Code "PDE"

FDA 510(k) Number	Applicant	Device Name	Decision Date
K140686	THE BINDING SITE GROUP LTD	HEVYLITE HUMAN IGM KAPPA AND LAMBDA KIT FOR USE ON SPAPLUS	08/06/2014
K152389	THE BINDING SITE GROUP LTD	Optilite Hevylite IgM Kappa Kit; Optilite Hevylite IgM Lambda Kit	12/18/2015