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The Binding Site Group , Ltd.

FDA 510(k) & PMA Approved Devices — 17 products

Total Devices17
Categories8
Latest FDA decision2025-10-17
TypeNumberDevice NameCodeDateActions
510(k) K250159 Immunoglobulin Isotypes (GAM) for the EXENT Analyser; EXENT AnalyserSGG2025-10-17 View
510(k) K250549 Optilite® Freelite Mx Kappa Free Kit; Optilite® Freelite Mx Lambda Free KitDFH2025-05-23 View
510(k) K192116 Human IgA liquid reagent kit for Use on SPAPlusCFN2019-09-04 View
510(k) K191985 Optilite IgA KitCFN2019-08-19 View
510(k) K191635 Optilite IgM KitCFN2019-07-15 View
510(k) K191465 Human IgM Kit for use on SPAPlusCFN2019-06-27 View
510(k) K190686 Optilite IgM CSF KitCFN2019-05-28 View
510(k) K183151 Optilite IgA CSF KitCFN2019-01-23 View
510(k) K180099 Optilite High Sensitivity C-Reactive Protein KitDCN2018-10-12 View
510(k) K173732 Optilite Freelite Mx Kappa Free Kit, Optilite Freelite Mx Lambda Free KitDFH2018-08-23 View
510(k) K172868 Optilite C-Reactive Protein Reagent,Optilite C-Reactive Protein Calibrator,Optilite C-Reactive Protein ControlsDCN2018-02-28 View
510(k) K172613 Optilite Hevylite IgG Kappa Kit, Optilite Hevylite IgG Lambda KitPCN2018-02-15 View
510(k) K162263 Optilite Rheumatoid Factor KitDHR2017-05-03 View
510(k) K160070 Rheumatoid Factor (RF) Kit for use on SPAPLUSDHR2016-12-07 View
510(k) K161854 Hevylite Human IgG Kappa Kit for use on the SPAPLUS, Hevylite Human IgG Lambda Kit for use on the SPAPLUSPCN2016-10-04 View
510(k) K153560 Optilite Low Level Albumin KitDCF2016-08-25 View
510(k) K160819 Optilite Hevylite IgA Kappa Kit, Optilite Hevylite IgA Lambda KitOPX2016-06-16 View
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