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The Binding Site Group , Ltd.

43 FDA 510(k) clearances · Manufacturer

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RecordFirmDate
Immunoglobulin Isotypes (GAM) for the EXENT Analyser; EXENT Analyser (K250159)The Binding Site Group , Ltd.2025-10-17
Optilite® Freelite Mx Kappa Free Kit; Optilite® Freelite Mx Lambda Free Kit (K250549)The Binding Site Group , Ltd.2025-05-23
Human IgA liquid reagent kit for Use on SPAPlus (K192116)The Binding Site Group , Ltd.2019-09-04
Optilite IgA Kit (K191985)The Binding Site Group , Ltd.2019-08-19
Optilite IgM Kit (K191635)The Binding Site Group , Ltd.2019-07-15
Human IgM Kit for use on SPAPlus (K191465)The Binding Site Group , Ltd.2019-06-27
Optilite IgM CSF Kit (K190686)The Binding Site Group , Ltd.2019-05-28
Optilite IgA CSF Kit (K183151)The Binding Site Group , Ltd.2019-01-23
Optilite High Sensitivity C-Reactive Protein Kit (K180099)The Binding Site Group , Ltd.2018-10-12
Optilite Freelite Mx Kappa Free Kit, Optilite Freelite Mx Lambda Free Kit (K173732)The Binding Site Group , Ltd.2018-08-23
Optilite C-Reactive Protein Reagent,Optilite C-Reactive Protein Calibrator,Optilite C-Reactive Protein Controls (K172868)The Binding Site Group , Ltd.2018-02-28
Optilite Hevylite IgG Kappa Kit, Optilite Hevylite IgG Lambda Kit (K172613)The Binding Site Group , Ltd.2018-02-15
Optilite Rheumatoid Factor Kit (K162263)The Binding Site Group , Ltd.2017-05-03
Rheumatoid Factor (RF) Kit for use on SPAPLUS (K160070)The Binding Site Group , Ltd.2016-12-07
Hevylite Human IgG Kappa Kit for use on the SPAPLUS, Hevylite Human IgG Lambda Kit for use on the SPAPLUS (K161854)The Binding Site Group , Ltd.2016-10-04
Optilite Low Level Albumin Kit (K153560)The Binding Site Group , Ltd.2016-08-25
Optilite Hevylite IgA Kappa Kit, Optilite Hevylite IgA Lambda Kit (K160819)The Binding Site Group , Ltd.2016-06-16
Optilite Hevylite IgM Kappa Kit; Optilite Hevylite IgM Lambda Kit (K152389)The Binding Site Group , Ltd.2015-12-18
Hevylite Human IgA Kappa Kit for use on SPAPLUS, Hevylite Human IgA Lambda Kit for use on SPAPLUS (K151759)The Binding Site Group , Ltd.2015-11-06
Optilite CH50 Reagent, Optilite CH50 Controls and Optilite CH50 Calibrator (K150412)The Binding Site Group , Ltd.2015-08-28
Optilite FreeLite Kappa Free Kit, Optilite Freelite Lambda Free Kit (K150658)The Binding Site Group , Ltd.2015-08-26
Optilite IgG4 Kit (K150526)The Binding Site Group , Ltd.2015-05-30
Human Microalbumin kit for use on SPAPLUS (K143118)The Binding Site Group , Ltd.2015-05-26
The Optilite IgG3 kit (K142735)The Binding Site Group , Ltd.2014-12-21
HEVYLITE HUMAN IGM KAPPA AND LAMBDA KIT FOR USE ON SPAPLUS (K140686)The Binding Site Group , Ltd.2014-08-06
OPTILITE C1 INACTIVATOR KIT (K141100)The Binding Site Group , Ltd.2014-07-18
FREELITE HUMAN LAMBDA FREE KIT (K140396)The Binding Site Group , Ltd.2014-04-16
HUMAN ALPHA2-MACROGLOBULIN KIT FOR USE ON SPAPLUS (K140664)The Binding Site Group , Ltd.2014-04-16
HUMAN ALPHA-1 ANTITRYPSIN KIT SPAPLUS (K123256)The Binding Site Group , Ltd.2013-07-03
HUMAN ALBUMIN CSF KIT (K121045)The Binding Site Group , Ltd.2013-06-19
HUMAN CAERULOPLASMIN KIT (K122965)The Binding Site Group , Ltd.2013-06-03
HUMAN IGA CSF KIT FOR USE ON SPAPLUS (K120901)The Binding Site Group , Ltd.2013-05-30
HUMAN IGG CSF KIT (K120749)The Binding Site Group , Ltd.2013-05-17
HUMAN IGM CSF KIT (K120750)The Binding Site Group , Ltd.2013-05-17
HUMAN C1 INACTIVATOR KIT FOR USE ON SPAPLUS (K122304)The Binding Site Group , Ltd.2013-04-15
HUMAN KAPPA AND LAMBDA FREE KITFOR USE ON THE SPA PLUS ANALYSER (K120056)The Binding Site Group , Ltd.2013-04-01
HEVYLITE HUMAN IGM KAPPA AND HEVYLITE IGM LAMBDA KIT (K113823)The Binding Site Group , Ltd.2013-03-27
TRANSFERRIN KIT FOR USE ON THE SPAPLUS (K120236)The Binding Site Group , Ltd.2013-02-13
HUMAN BETA-2 MICROGLOBULIN URINE KIT FOR USE ON THE SPAPLUS (K122066)The Binding Site Group , Ltd.2012-08-30
HUMAN CH50 REAGENT PACK FOR USE ON THE SPAPLUS, HUMAN CH50 CALIBRATOR SET FOR USE ON THE SPAPLUS, HUMAN CH50 CONTROLS FO (K113349)The Binding Site Group , Ltd.2012-07-11
HUMAN IGA2 KIT FOR USE ON THE SPAPLUS (K100588)The Binding Site Group , Ltd.2010-08-16
SPAPLUS (K100179)The Binding Site Group , Ltd.2010-08-13
HEVYLITE HUMAN IGA KAPPA AND IGA LAMBDA BN KITS (K082823)The Binding Site Group , Ltd.2010-03-01

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Every clearance here is in the API, with alerts when new ones post.