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

FDA 510(k) Number Submission Date Device Name Applicant
K172613 08/31/2017 Optilite Hevylite IgG Kappa Kit, Optilite Hevylite IgG Lambda Kit The Binding Site Group Ltd.
K160819 03/24/2016 Optilite Hevylite IgA Kappa Kit, Optilite Hevylite IgA Lambda Kit THE BINDING SITE GROUP LTD.
K162263 08/11/2016 Optilite Rheumatoid Factor Kit THE BINDING SITE GROUP LTD.
K190686 03/18/2019 Optilite IgM CSF Kit The Binding Site Group Ltd.
K172868 09/20/2017 Optilite C-Reactive Protein Reagent,Optilite C-Reactive Protein Calibrator,Optilite C-Reactive Protein Controls The Binding Site Group Ltd.
K191465 06/03/2019 Human IgM Kit for use on SPAPlus The Binding Site Group Ltd.
K191635 06/19/2019 Optilite IgM Kit The Binding Site Group Ltd.
K191985 07/25/2019 Optilite IgA Kit The Binding Site Group Ltd.
K183151 11/14/2018 Optilite IgA CSF Kit The Binding Site Group Ltd.
K151759 06/29/2015 Hevylite Human IgA Kappa Kit for use on SPAPLUS, Hevylite Human IgA Lambda Kit for use on SPAPLUS THE BINDING SITE GROUP LTD.


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