Medical Device Manufacturer · US , Los Angeles , CA

The Binding Site Group , Ltd.

43 submissions · 43 cleared · Since 2010
43
Total
43
Cleared
0
Denied

The Binding Site Group , Ltd. — FDA 510(k) Submissions

The Binding Site Group , Ltd. has submitted 43 FDA 510(k) premarket notifications since 2010, of which 43 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Method, Nephelometric, Immunoglobulins (g, A, M), Kappa, Antigen, Antiserum, Control, Albumin, Antigen, Antiserum, Control, Immunoglobulin A Kappa Heavy & Light Chain Combined, System, Test, Rheumatoid Factor . Use the specialty filter in the sidebar to narrow results.

43 devices
1–25 of 43
Immunoglobulin Isotypes (GAM) for the EXENT Analyser; EXENT Analyser
K250159 · SGG Mass Spectrometric,... · Immunology
Oct 2025 269d
Optilite? Freelite Mx Kappa Free Kit; Optilite? Freelite Mx Lambda Free Kit
K250549 · DFH Kappa, Antigen,... · Immunology
May 2025 87d
Human IgA liquid reagent kit for Use on SPAPlus
K192116 · CFN Method, Nephelometric,... · Immunology
Sep 2019 29d
Optilite IgA Kit
K191985 · CFN Method, Nephelometric,... · Immunology
Aug 2019 25d
Optilite IgM Kit
K191635 · CFN Method, Nephelometric,... · Immunology
Jul 2019 26d
Human IgM Kit for use on SPAPlus
K191465 · CFN Method, Nephelometric,... · Immunology
Jun 2019 24d
Optilite IgM CSF Kit
K190686 · CFN Method, Nephelometric,... · Immunology
May 2019 71d
Optilite IgA CSF Kit
K183151 · CFN Method, Nephelometric,... · Immunology
Jan 2019 70d
Optilite High Sensitivity C-Reactive Protein Kit
K180099 · DCN System, Test, C-reactive... · Chemistry
Oct 2018 269d
Optilite Freelite Mx Kappa Free Kit, Optilite Freelite Mx Lambda Free Kit
K173732 · DFH Kappa, Antigen,... · Immunology
Aug 2018 260d
Optilite C-Reactive Protein Reagent,Optilite C-Reactive Protein Calibrator,Optilite C-Reactive Protein Controls
K172868 · DCN System, Test, C-reactive... · Immunology
Feb 2018 161d
Optilite Hevylite IgG Kappa Kit, Optilite Hevylite IgG Lambda Kit
K172613 · PCN Immunoglobulin G Kappa... · Immunology
Feb 2018 168d
Optilite Rheumatoid Factor Kit
K162263 · DHR System, Test, Rheumatoid... · Immunology
May 2017 265d
Rheumatoid Factor (RF) Kit for use on SPAPLUS
K160070 · DHR System, Test, Rheumatoid... · Immunology
Dec 2016 329d
Hevylite Human IgG Kappa Kit for use on the SPAPLUS, Hevylite Human IgG Lambda Kit for use on the SPAPLUS
K161854 · PCN Immunoglobulin G Kappa... · Immunology
Oct 2016 90d
Optilite Low Level Albumin Kit
K153560 · DCF Albumin, Antigen,... · Immunology
Aug 2016 255d
Optilite Hevylite IgA Kappa Kit, Optilite Hevylite IgA Lambda Kit
K160819 · OPX Immunoglobulin A Kappa... · Immunology
Jun 2016 84d
Optilite Hevylite IgM Kappa Kit; Optilite Hevylite IgM Lambda Kit
K152389 · PDE Immunoglobulin M Kappa... · Immunology
Dec 2015 116d
Hevylite Human IgA Kappa Kit for use on SPAPLUS, Hevylite Human IgA Lambda Kit for use on SPAPLUS
K151759 · OPX Immunoglobulin A Kappa... · Immunology
Nov 2015 130d
Optilite CH50 Reagent, Optilite CH50 Controls and Optilite CH50 Calibrator
K150412 · DAE Complement C9, Antigen,... · Immunology
Aug 2015 191d
Optilite FreeLite Kappa Free Kit, Optilite Freelite Lambda Free Kit
K150658 · DFH Kappa, Antigen,... · Immunology
Aug 2015 166d
Optilite IgG4 Kit
K150526 · CFN Method, Nephelometric,... · Immunology
May 2015 89d
Human Microalbumin kit for use on SPAPLUS
K143118 · DCF Albumin, Antigen,... · Chemistry
May 2015 208d
The Optilite IgG3 kit
K142735 · CFN Method, Nephelometric,... · Immunology
Dec 2014 89d
HEVYLITE HUMAN IGM KAPPA AND LAMBDA KIT FOR USE ON SPAPLUS
K140686 · PDE Immunoglobulin M Kappa... · Immunology
Aug 2014 140d
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