Data / Medical devices / United Kingdom / The Binding Site
The Binding Site: FDA-registered device maker in Kings Norton Birmingham, United Kingdom, 64 510(k) clearances
The Binding Site is registered with the FDA (registration 3012471076) in Kings Norton Birmingham, United Kingdom. It lists 50 device types. The FDA files 64 510(k) clearances under its listings, the newest dated October 17, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3012471076
- Address
- Unit 27-29, 31-33 Sovereign Road Kings Norton Business Centre, Kings Norton Birmingham, United Kingdom, B30 3HN
- Owner or operator
- THE BINDING SITE (9008308)
- Roles
- Complaint file establishment, Exporter to the US, Manufacturer, Repackager or relabeler
- First device listed
- August 28, 1996
- Registered through
- 2026
- Brand names listed
- ANIT-HAEMOPHILUS B ELI, Alpha 1 Acid Glycoprotein AMR Fluid, Antistreptolysin O AMR Fluid, B2M Analytical Measuring Range Fluid, C1q complement NL RID kit, CH50 ELISA assay, Complement C2 Calibrator Set, Cystatin C Analytical Measuring Range and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 17, 2025 | K250159 | Immunoglobulin Isotypes (GAM) for the EXENT Analyser; EXENT Analyser | SGG | Substantially Equivalent | The Binding Site Group , Ltd. | accessdata.fda.gov |
| May 23, 2025 | K250549 | Optilite® Freelite Mx Kappa Free Kit; Optilite® Freelite Mx Lambda Free Kit | DFH | Substantially Equivalent | The Binding Site Group , Ltd. | accessdata.fda.gov |
| January 24, 2024 | K231290 | Optilite® Freelite® Kappa Free Kit, Optilite® Freelite® Lambda Free Kit | DFH | Substantially Equivalent | The Binding Site, Ltd. | accessdata.fda.gov |
| August 19, 2019 | K191985 | Optilite IgA Kit | CFN | Substantially Equivalent | The Binding Site Group , Ltd. | accessdata.fda.gov |
| July 15, 2019 | K191635 | Optilite IgM Kit | CFN | Substantially Equivalent | The Binding Site Group , Ltd. | accessdata.fda.gov |
| May 28, 2019 | K190686 | Optilite IgM CSF Kit | CFN | Substantially Equivalent | The Binding Site Group , Ltd. | accessdata.fda.gov |
| January 23, 2019 | K183151 | Optilite IgA CSF Kit | CFN | Substantially Equivalent | The Binding Site Group , Ltd. | accessdata.fda.gov |
| October 12, 2018 | K180099 | Optilite High Sensitivity C-Reactive Protein Kit | DCN | Substantially Equivalent | The Binding Site Group , Ltd. | accessdata.fda.gov |
| August 23, 2018 | K173732 | Optilite Freelite Mx Kappa Free Kit, Optilite Freelite Mx Lambda Free Kit | DFH | Substantially Equivalent | The Binding Site Group , Ltd. | accessdata.fda.gov |
| February 28, 2018 | K172868 | Optilite C-Reactive Protein Reagent,Optilite C-Reactive Protein Calibrator,Optilite C-Reactive Protein Controls | DCN | Substantially Equivalent | The Binding Site Group , Ltd. | accessdata.fda.gov |
| February 15, 2018 | K172613 | Optilite Hevylite IgG Kappa Kit, Optilite Hevylite IgG Lambda Kit | PCN | Substantially Equivalent | The Binding Site Group , Ltd. | accessdata.fda.gov |
| May 3, 2017 | K162263 | Optilite Rheumatoid Factor Kit | DHR | Substantially Equivalent | The Binding Site Group , Ltd. | accessdata.fda.gov |
| October 4, 2016 | K161854 | Hevylite Human IgG Kappa Kit for use on the SPAPLUS, Hevylite Human IgG Lambda Kit for use on the SPAPLUS | PCN | Substantially Equivalent | The Binding Site Group , Ltd. | accessdata.fda.gov |
| August 25, 2016 | K153560 | Optilite Low Level Albumin Kit | DCF | Substantially Equivalent | The Binding Site Group , Ltd. | accessdata.fda.gov |
| June 16, 2016 | K160819 | Optilite Hevylite IgA Kappa Kit, Optilite Hevylite IgA Lambda Kit | OPX | Substantially Equivalent | The Binding Site Group , Ltd. | accessdata.fda.gov |
| December 18, 2015 | K152389 | Optilite Hevylite IgM Kappa Kit; Optilite Hevylite IgM Lambda Kit | PDE | Substantially Equivalent | The Binding Site Group , Ltd. | accessdata.fda.gov |
| November 6, 2015 | K151759 | Hevylite Human IgA Kappa Kit for use on SPAPLUS, Hevylite Human IgA Lambda Kit for use on SPAPLUS | OPX | Substantially Equivalent | The Binding Site Group , Ltd. | accessdata.fda.gov |
| August 28, 2015 | K150412 | Optilite CH50 Reagent, Optilite CH50 Controls and Optilite CH50 Calibrator | DAE | Substantially Equivalent | The Binding Site Group , Ltd. | accessdata.fda.gov |
| August 26, 2015 | K150658 | Optilite FreeLite Kappa Free Kit, Optilite Freelite Lambda Free Kit | DFH | Substantially Equivalent | The Binding Site Group , Ltd. | accessdata.fda.gov |
| May 30, 2015 | K150526 | Optilite IgG4 Kit | CFN | Substantially Equivalent | The Binding Site Group , Ltd. | accessdata.fda.gov |
| May 26, 2015 | K143118 | Human Microalbumin kit for use on SPAPLUS | DCF | Substantially Equivalent | The Binding Site Group , Ltd. | accessdata.fda.gov |
| December 21, 2014 | K142735 | The Optilite IgG3 kit | CFN | Substantially Equivalent | The Binding Site Group , Ltd. | accessdata.fda.gov |
| August 6, 2014 | K140686 | HEVYLITE HUMAN IGM KAPPA AND LAMBDA KIT FOR USE ON SPAPLUS | PDE | Substantially Equivalent | The Binding Site Group , Ltd. | accessdata.fda.gov |
| July 18, 2014 | K141100 | OPTILITE C1 INACTIVATOR KIT | DBA | Substantially Equivalent | The Binding Site Group , Ltd. | accessdata.fda.gov |
| April 16, 2014 | K140664 | HUMAN ALPHA2-MACROGLOBULIN KIT FOR USE ON SPAPLUS | DEB | Substantially Equivalent | The Binding Site Group , Ltd. | accessdata.fda.gov |
| March 18, 2014 | K140105 | HEVYLITE HUMAN IGA KAPPA KIT FOR USE ON SIEMENS BNII, HEVYLITE HUMAN IGA LAMBDA KIT FOR USE ON SIEMENS BNII | OPX | Substantially Equivalent | The Binding Site | accessdata.fda.gov |
| December 20, 2013 | K132555 | HEVYLITE HUMAN IGG KAPPA KIT AND HEVYLITE HUMAN IGG LAMBDA KIT | PCN | Substantially Equivalent | The Binding Site | accessdata.fda.gov |
| July 3, 2013 | K123256 | HUMAN ALPHA-1 ANTITRYPSIN KIT SPAPLUS | DEM | Substantially Equivalent | The Binding Site Group , Ltd. | accessdata.fda.gov |
| June 19, 2013 | K121045 | HUMAN ALBUMIN CSF KIT | DCF | Substantially Equivalent | The Binding Site Group , Ltd. | accessdata.fda.gov |
| June 3, 2013 | K122965 | HUMAN CAERULOPLASMIN KIT | DDB | Substantially Equivalent | The Binding Site Group , Ltd. | accessdata.fda.gov |
| May 17, 2013 | K120749 | HUMAN IGG CSF KIT | CFN | Substantially Equivalent | The Binding Site Group , Ltd. | accessdata.fda.gov |
| March 27, 2013 | K113823 | HEVYLITE HUMAN IGM KAPPA AND HEVYLITE IGM LAMBDA KIT | CFN | Substantially Equivalent | The Binding Site Group , Ltd. | accessdata.fda.gov |
| February 13, 2013 | K120236 | TRANSFERRIN KIT FOR USE ON THE SPAPLUS | DDG | Substantially Equivalent | The Binding Site Group , Ltd. | accessdata.fda.gov |
| August 30, 2012 | K122066 | HUMAN BETA-2 MICROGLOBULIN URINE KIT FOR USE ON THE SPAPLUS | JZG | Substantially Equivalent | The Binding Site Group , Ltd. | accessdata.fda.gov |
| September 3, 2010 | K100455 | SPAPLUS ANALYZER | DBI | Substantially Equivalent | The Binding Site | accessdata.fda.gov |
| August 16, 2010 | K100588 | HUMAN IGA2 KIT FOR USE ON THE SPAPLUS | CFN | Substantially Equivalent | The Binding Site Group , Ltd. | accessdata.fda.gov |
| August 13, 2010 | K100179 | SPAPLUS | CZW | Substantially Equivalent | The Binding Site Group , Ltd. | accessdata.fda.gov |
| December 30, 2009 | K090920 | HUMAN IGG SUBCLASS LIQUID REAGENT KITS (FOR USE ON HITACHI 911/ 912/ 917 AND MODULAR P) | CFN | Substantially Equivalent | The Binding Site, Ltd. | accessdata.fda.gov |
| December 28, 2009 | K092450 | HUMAN IGD KIT FOR USE ON SPAPLUS | CZJ | Substantially Equivalent | The Binding Site | accessdata.fda.gov |
| May 6, 2009 | K083289 | HUMAN BETA-2 MICROGLOBULIN KIT | JZG | Substantially Equivalent | The Binding Site, Ltd. | accessdata.fda.gov |
| February 10, 2009 | K082129 | HUMAN IGM LIQUID REAGENT KIT FOR USE ON THE SPAPLUS ANALYZER | CFN | Substantially Equivalent | The Binding Site, Ltd. | accessdata.fda.gov |
| December 19, 2008 | K081827 | HUMAN IGA LIQUID REAGENT KIT FOR USE ON SPAPLUS | CFN | Substantially Equivalent | The Binding Site, Ltd. | accessdata.fda.gov |
| February 1, 2008 | K072889 | HUMAN IGG SUBCLASS LIQUID REAGENT KITS FOR USE ON THE SPAPLUS ANALYSER | CFN | Substantially Equivalent | The Binding Site, Ltd. | accessdata.fda.gov |
| January 24, 2008 | K072166 | CYSTATIN C KIT FOR USE ON THE SPAPLUS ANALYZER | NDY | Substantially Equivalent | The Binding Site | accessdata.fda.gov |
| November 30, 2007 | K070900 | FREELITE HUMAN KAPPA AND LAMBDA FREE DIAGNOSTIC TEST KITS FOR USE ON THE ROCHE COBAS INTEGRA 400/400 PLUS ANALYZER KIT | DFH | Substantially Equivalent | The Binding Site, Ltd. | accessdata.fda.gov |
| November 23, 2005 | K051299 | IGD DIAGNOSTIC TEST KITS | CZJ | Substantially Equivalent | The Binding Site, Ltd. | accessdata.fda.gov |
| September 6, 2005 | K051915 | FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE BAYER ADVIA 1650 ANALYZER | DFH | Substantially Equivalent | The Binding Site, Ltd. | accessdata.fda.gov |
| November 22, 2004 | K042152 | BINDING SITE IGG SUBLCASS OLYMPUS KITS | CFN | Substantially Equivalent | The Binding Site | accessdata.fda.gov |
| March 11, 2004 | K040009 | FREELITE HUMAN KAPPA AND LAMBDA KITS | DFH | Substantially Equivalent | The Binding Site, Ltd. | accessdata.fda.gov |
| January 30, 2004 | K033811 | FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE OLYMPUS AU ANALYZER | DEH | Substantially Equivalent | The Binding Site, Ltd. | accessdata.fda.gov |
| July 15, 2003 | K031016 | FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE DAD BEHRING NEPHELOMETER II | DEH | Substantially Equivalent | The Binding Site, Ltd. | accessdata.fda.gov |
| August 31, 2001 | K012292 | HUMAN IGG SUBCLASS LIQUID REAGENT KITS, PRODUCT CODE LK001.TB | CFN | Substantially Equivalent | The Binding Site, Ltd. | accessdata.fda.gov |
| April 26, 2001 | K010441 | FREELITE KAPPA FREE KIT | DEH | Substantially Equivalent | The Binding Site, Ltd. | accessdata.fda.gov |
| April 26, 2001 | K010440 | FREELITE LAMBDA FREE KIT | DEH | Substantially Equivalent | The Binding Site, Ltd. | accessdata.fda.gov |
| October 26, 2000 | K002560 | SHEEP ANTI-HUMAN IGE IMMUNOFIXATION GRADE KIT | DGC | Substantially Equivalent | The Binding Site, Ltd. | accessdata.fda.gov |
| December 20, 1999 | K981785 | C4 MININEPH ANTISERUM | DBI | Substantially Equivalent | The Binding Site, Ltd. | accessdata.fda.gov |
| December 4, 1998 | K981912 | HUMAN IGA SUBCLASS BNII COMBI KIT | CFN | Substantially Equivalent | The Binding Site, Ltd. | accessdata.fda.gov |
| July 29, 1998 | K974111 | QUIDEL CH50 EQ EIA | DAE | Substantially Equivalent | Quidel Corp. | accessdata.fda.gov |
| August 24, 1995 | K942326 | HUMAN C5 RID KITS | DAY | Substantially Equivalent | Jay H. Geller | accessdata.fda.gov |
| January 3, 1992 | K913667 | ANTITHROMBIN III IMMUNOLOGICAL NL TEST KIT | JBQ | Substantially Equivalent | The Binding Site, Ltd. | accessdata.fda.gov |
| December 20, 1991 | K913672 | PREALBUMIN IMMUNOLOGICAL NL TEST KIT | JZJ | Substantially Equivalent | The Binding Site, Ltd. | accessdata.fda.gov |
| December 20, 1991 | K913668 | CAERULOPLASMIN IMMUNOLOGICAL NL TEST KIT | DDB | Substantially Equivalent | The Binding Site, Ltd. | accessdata.fda.gov |
| October 28, 1991 | K914388 | C1 RID KIT | DAK | Substantially Equivalent | The Binding Site, Ltd. | accessdata.fda.gov |
| July 22, 1991 | K905633 | HUMAN C-REACTIVE PROTEIN RID KIT | DCK | Substantially Equivalent | The Binding Site, Ltd. | accessdata.fda.gov |
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Updated October 17, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.