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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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