The Binding Site Group , Ltd.
FDA 510(k) & PMA Approved Devices — 17 products
Total Devices17
Categories8
Latest Approval2025-10-17
| Type | Number | Device Name | Code | Date | |
|---|---|---|---|---|---|
| 510(k) | K250159 | Immunoglobulin Isotypes (GAM) for the EXENT Analyser; EXENT Analyser | SGG | 2025-10-17 | View |
| 510(k) | K250549 | Optilite® Freelite Mx Kappa Free Kit; Optilite® Freelite Mx Lambda Free Kit | DFH | 2025-05-23 | View |
| 510(k) | K192116 | Human IgA liquid reagent kit for Use on SPAPlus | CFN | 2019-09-04 | View |
| 510(k) | K191985 | Optilite IgA Kit | CFN | 2019-08-19 | View |
| 510(k) | K191635 | Optilite IgM Kit | CFN | 2019-07-15 | View |
| 510(k) | K191465 | Human IgM Kit for use on SPAPlus | CFN | 2019-06-27 | View |
| 510(k) | K190686 | Optilite IgM CSF Kit | CFN | 2019-05-28 | View |
| 510(k) | K183151 | Optilite IgA CSF Kit | CFN | 2019-01-23 | View |
| 510(k) | K180099 | Optilite High Sensitivity C-Reactive Protein Kit | DCN | 2018-10-12 | View |
| 510(k) | K173732 | Optilite Freelite Mx Kappa Free Kit, Optilite Freelite Mx Lambda Free Kit | DFH | 2018-08-23 | View |
| 510(k) | K172868 | Optilite C-Reactive Protein Reagent,Optilite C-Reactive Protein Calibrator,Optilite C-Reactive Protein Controls | DCN | 2018-02-28 | View |
| 510(k) | K172613 | Optilite Hevylite IgG Kappa Kit, Optilite Hevylite IgG Lambda Kit | PCN | 2018-02-15 | View |
| 510(k) | K162263 | Optilite Rheumatoid Factor Kit | DHR | 2017-05-03 | View |
| 510(k) | K160070 | Rheumatoid Factor (RF) Kit for use on SPAPLUS | DHR | 2016-12-07 | View |
| 510(k) | K161854 | Hevylite Human IgG Kappa Kit for use on the SPAPLUS, Hevylite Human IgG Lambda Kit for use on the SPAPLUS | PCN | 2016-10-04 | View |
| 510(k) | K153560 | Optilite Low Level Albumin Kit | DCF | 2016-08-25 | View |
| 510(k) | K160819 | Optilite Hevylite IgA Kappa Kit, Optilite Hevylite IgA Lambda Kit | OPX | 2016-06-16 | View |
No matching devices.