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

FDA 510(k) Number Applicant Device Name Decision Date
K132555 THE BINDING SITE HEVYLITE HUMAN IGG KAPPA KIT AND HEVYLITE HUMAN IGG LAMBDA KIT 12/20/2013
K161854 THE BINDING SITE GROUP LTD Hevylite Human IgG Kappa Kit for use on the SPAPLUS, Hevylite Human IgG Lambda Kit for use on the SPAPLUS 10/04/2016
K172613 The Binding Site Group Ltd. Optilite Hevylite IgG Kappa Kit, Optilite Hevylite IgG Lambda Kit 02/15/2018


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