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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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