FDA 510(k) Applications Submitted by The Binding Site Group Ltd

FDA 510(k) Number Submission Date Device Name Applicant
K150526 03/02/2015 Optilite IgG4 Kit THE BINDING SITE GROUP LTD
K150658 03/13/2015 Optilite FreeLite Kappa Free Kit, Optilite Freelite Lambda Free Kit THE BINDING SITE GROUP LTD
K161854 07/06/2016 Hevylite Human IgG Kappa Kit for use on the SPAPLUS, Hevylite Human IgG Lambda Kit for use on the SPAPLUS THE BINDING SITE GROUP LTD
K142735 09/23/2014 The Optilite IgG3 kit THE BINDING SITE GROUP LTD
K173732 12/06/2017 Optilite Freelite Mx Kappa Free Kit, Optilite Freelite Mx Lambda Free Kit The Binding Site Group Ltd
K100588 03/02/2010 HUMAN IGA2 KIT FOR USE ON THE SPAPLUS THE BINDING SITE GROUP LTD
K082823 09/25/2008 HEVYLITE HUMAN IGA KAPPA AND IGA LAMBDA BN KITS THE BINDING SITE GROUP LTD
K120056 01/09/2012 HUMAN KAPPA AND LAMBDA FREE KITFOR USE ON THE SPA PLUS ANALYSER THE BINDING SITE GROUP LTD
K120236 01/26/2012 TRANSFERRIN KIT FOR USE ON THE SPAPLUS THE BINDING SITE GROUP LTD
K120749 03/12/2012 HUMAN IGG CSF KIT THE BINDING SITE GROUP LTD
K120750 03/12/2012 HUMAN IGM CSF KIT THE BINDING SITE GROUP LTD
K122066 07/16/2012 HUMAN BETA-2 MICROGLOBULIN URINE KIT FOR USE ON THE SPAPLUS THE BINDING SITE GROUP LTD
K113823 12/27/2011 HEVYLITE HUMAN IGM KAPPA AND HEVYLITE IGM LAMBDA KIT THE BINDING SITE GROUP LTD
K153560 12/14/2015 Optilite Low Level Albumin Kit THE BINDING SITE GROUP LTD
K180099 01/16/2018 Optilite High Sensitivity C-Reactive Protein Kit The Binding Site Group Ltd
K150412 02/18/2015 Optilite CH50 Reagent, Optilite CH50 Controls and Optilite CH50 Calibrator The Binding Site Group Ltd
K141100 04/29/2014 OPTILITE C1 INACTIVATOR KIT THE BINDING SITE GROUP LTD
K143118 10/30/2014 Human Microalbumin kit for use on SPAPLUS THE BINDING SITE GROUP LTD
K113349 11/14/2011 HUMAN CH50 REAGENT PACK FOR USE ON THE SPAPLUS, HUMAN CH50 CALIBRATOR SET FOR USE ON THE SPAPLUS, HUMAN CH50 CONTROLS FO THE BINDING SITE GROUP LTD
K192116 08/06/2019 Human IgA liquid reagent kit for Use on SPAPlus The Binding Site Group Ltd
K152389 08/24/2015 Optilite Hevylite IgM Kappa Kit; Optilite Hevylite IgM Lambda Kit THE BINDING SITE GROUP LTD
K140686 03/19/2014 HEVYLITE HUMAN IGM KAPPA AND LAMBDA KIT FOR USE ON SPAPLUS THE BINDING SITE GROUP LTD


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