Company · US
The Binding Site, Ltd.
FDA 510(k) clearances and medical device recalls filed under this name, 1988 to 2024. Name variants (Inc, Corp, punctuation) are merged.
125510(k) clearances (0 in 12 months)
1recalls (0 in 12 months)
1recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| CFN | Method, Nephelometric, Immunoglobulins (G, A, M) | 15 |
| DFH | Kappa, Antigen, Antiserum, Control | 8 |
| DEH | Lambda, Antigen, Antiserum, Control | 7 |
| JZG | System, Test, Beta-2-Microglobulin Immunological | 6 |
| MID | System, Test, Anticardiolipin Immunological | 6 |
| LLL | Extractable Antinuclear Antibody, Antigen And Control | 5 |
| CFQ | Radioimmunoassay, Immunoglobulins (G, A, M) | 4 |
| CZJ | Igd, Antigen, Antiserum, Control | 4 |
| MOB | Test System, Antineutrophil Cytoplasmic Antibodies (Anca) | 4 |
| MSV | System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi) | 4 |
| DCK | C-Reactive Protein, Antigen, Antiserum, And Control | 3 |
| MST | Antibodies, Gliadin | 3 |
| MVM | Autoantibodies, Endomysial(Tissue Transglutaminase) | 3 |
| CFF | Immunoelectrophoretic, Immunoglobulins, (G, A, M) | 2 |
| CZS | Retinol-Binding Protein, Antigen, Antiserum, Control | 2 |
| CZW | Complement C3, Antigen, Antiserum, Control | 2 |
| DAK | Complement C1q, Antigen, Antiserum, Control | 2 |
| DBI | Complement C4, Antigen, Antiserum, Control | 2 |
| DDG | Transferrin, Antigen, Antiserum, Control | 2 |
| DEM | Alpha-1-Antitrypsin, Antigen, Antiserum, Control | 2 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 24, 2024 | K231290 | Optilite® Freelite® Kappa Free Kit, Optilite® Freelite® Lambda Free Kit The Binding Site, Ltd., GB | DFH |
| Mar 18, 2014 | K140105 | HEVYLITE HUMAN IGA KAPPA KIT FOR USE ON SIEMENS BNII, HEVYLITE HUMAN IGA LAMBDA KIT FOR USE ON SIEMENS BNII The Binding Site, GB | OPX |
| Dec 20, 2013 | K132555 | HEVYLITE HUMAN IGG KAPPA KIT AND HEVYLITE HUMAN IGG LAMBDA KIT The Binding Site, GB | PCN |
| Feb 27, 2012 | K103824 | HUMAN IGA LIQUID REAGENT KIT FOR USE ON SPA PLUS The Binding Site, GB | CFN |
| Sep 3, 2010 | K100455 | SPAPLUS ANALYZER The Binding Site | DBI |
| Dec 30, 2009 | K090920 | HUMAN IGG SUBCLASS LIQUID REAGENT KITS (FOR USE ON HITACHI 911/ 912/ 917 AND MODULAR P) The Binding Site, Ltd. | CFN |
| Dec 28, 2009 | K092450 | HUMAN IGD KIT FOR USE ON SPAPLUS The Binding Site | CZJ |
| May 6, 2009 | K083289 | HUMAN BETA-2 MICROGLOBULIN KIT The Binding Site, Ltd. | JZG |
| Feb 10, 2009 | K082129 | HUMAN IGM LIQUID REAGENT KIT FOR USE ON THE SPAPLUS ANALYZER The Binding Site, Ltd. | CFN |
| Dec 19, 2008 | K081827 | HUMAN IGA LIQUID REAGENT KIT FOR USE ON SPAPLUS The Binding Site, Ltd. | CFN |
| Oct 15, 2008 | K081674 | BINDAZYME HUMAN ANTI-GLIADIN (MGP), IGG EIA KIT; BINDAZYME HUMAN ANTI-GLIADIN (MGP) IGA EIA KIT; (IGA OR IGG) The Binding Site, Ltd. | MST |
| Jun 6, 2008 | K080384 | HUMAN CYSTATIN C KIT FOR USE ON MODULAR P ANALYSER The Binding Site, Ltd. | NDY |
| Feb 1, 2008 | K072889 | HUMAN IGG SUBCLASS LIQUID REAGENT KITS FOR USE ON THE SPAPLUS ANALYSER The Binding Site, Ltd. | CFN |
| Jan 24, 2008 | K072166 | CYSTATIN C KIT FOR USE ON THE SPAPLUS ANALYZER The Binding Site | NDY |
| Nov 30, 2007 | K070900 | FREELITE HUMAN KAPPA AND LAMBDA FREE DIAGNOSTIC TEST KITS FOR USE ON THE ROCHE COBAS INTEGRA 400/400 PLUS ANALYZER KIT The Binding Site, Ltd. | DFH |
| Jun 21, 2007 | K062372 | FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE SPAPLUS ANALYZER The Binding Site, Ltd. | DFH |
| Nov 21, 2006 | K062183 | FARRZYME HUMAN HIGH AVIDITY ANTI-DSDNA ENZYME IMMUNOASSAY KIT The Binding Site, Ltd. | LRM |
| Nov 23, 2005 | K051299 | IGD DIAGNOSTIC TEST KITS The Binding Site, Ltd. | CZJ |
| Sep 6, 2005 | K051915 | FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE BAYER ADVIA 1650 ANALYZER The Binding Site, Ltd. | DFH |
| Jul 28, 2005 | K042579 | BINDAZYME HUMAN ASCA IGG AND IGA EIA DIAGNOSTIC TEST KIT The Binding Site | NBT |
| Nov 22, 2004 | K042152 | BINDING SITE IGG SUBLCASS OLYMPUS KITS The Binding Site | CFN |
| Nov 5, 2004 | K041891 | MININEPH HUMAN RHEUMATOID FACTOR KIT The Binding Site | DHR |
| Jul 16, 2004 | K040466 | BINDAZYME HUMAN ANTI TISSUE TRANSGLUTAMINASE IGA AND IGG EIA DIAGNOSTIC TEST KITS The Binding Site | MVM |
| Mar 11, 2004 | K040009 | FREELITE HUMAN KAPPA AND LAMBDA KITS The Binding Site, Ltd. | DFH |
| Jan 30, 2004 | K033811 | FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE OLYMPUS AU ANALYZER The Binding Site, Ltd. | DEH |
| Sep 29, 2003 | K032240 | BINDAZYME HUMAN ANTI-PHOSPHATIDYLSERINE IGA, IGG AND IGM ENZYME IMMUNOASSAY KIT The Binding Site, Ltd. | MID |
| Sep 10, 2003 | K031563 | BINDAZYME CLQ CIC EIA KIT The Binding Site, Ltd. | DAK |
| Jul 15, 2003 | K031016 | FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE DAD BEHRING NEPHELOMETER II The Binding Site, Ltd. | DEH |
| Mar 24, 2003 | K030238 | BINDAZYME ANTI-MITOCHONDRIA M2 IGGAM EIA KIT The Binding Site, Ltd. | DBM |
| Jan 21, 2003 | K023131 | FREELITE HUMAN LAMBDA FREE KIT The Binding Site, Ltd. | DEH |
| Jan 21, 2003 | K023009 | FREELITE HUMAN KAPPA AND HUMAN LAMBDA FREE KITS FOR USE ON THE HITACHI 911/912 ANALYZER The Binding Site, Ltd. | DFH |
| Aug 15, 2002 | K014270 | MININEPH HUMAN B2-MICROGLOBULIN KIT The Binding Site, Ltd. | JZG |
| Jul 16, 2002 | K022083 | HUMAN IGG SUBCLASS KIT FOR USE ON THE BECKMAN IMMAGE ANALYSER The Binding Site, Ltd. | CFN |
| Jun 17, 2002 | K021081 | HUMAN IGG SUBCLASS LIQUID REAGENT KITS FOR USE ON THE HITACHI 911/7070 TURBIDIMETRIC ANALYSER The Binding Site, Ltd. | DFZ |
| Aug 31, 2001 | K012296 | HUMAN IGG SUBCLASS LIQUID REAGENT KITS, PRODUCT CODE LK001.T The Binding Site, Ltd. | CFN |
| Aug 31, 2001 | K012292 | HUMAN IGG SUBCLASS LIQUID REAGENT KITS, PRODUCT CODE LK001.TB The Binding Site, Ltd. | CFN |
| Aug 20, 2001 | K012295 | HUMAN IGG SUBCLASS LIQUID REAGENT KITS, PRODUCT CODE NK001.T The Binding Site, Ltd. | CFN |
| Aug 20, 2001 | K012291 | HUMAN IGG SUBCLASS LIQUID REAGENT KITS, PRODUCT CODE LK001.TA The Binding Site, Ltd. | CFN |
| Jul 30, 2001 | K011663 | MININEPH A-1 ANTITRYPSIN ANTISERUM, HIGH AND LOW SERUM CONTROLS The Binding Site, Ltd. | DEM |
| Jul 30, 2001 | K011662 | MININEPH A-1 TRANSFERRIN ANTISERUM, HIGH AND LOW SERUM CONTROL The Binding Site, Ltd. | DDG |
| Apr 26, 2001 | K010441 | FREELITE KAPPA FREE KIT The Binding Site, Ltd. | DEH |
| Apr 26, 2001 | K010440 | FREELITE LAMBDA FREE KIT The Binding Site, Ltd. | DEH |
| Mar 1, 2001 | K010147 | ENA EIA KIT The Binding Site, Ltd. | LLL |
| Mar 1, 2001 | K010146 | ENA EIA KIT RANGE The Binding Site, Ltd. | LLL |
| Feb 23, 2001 | K010148 | ENA SCREEN EIA KIT The Binding Site, Ltd. | LLL |
| Feb 15, 2001 | K004019 | ANA EIA DIAGNOSTIC TEST KIT The Binding Site, Ltd. | LJM |
| Feb 1, 2001 | K003671 | LAMBDA IMMAGE FREELITE KIT The Binding Site, Ltd. | DEH |
| Feb 1, 2001 | K003669 | KAPPA IMMAGE FREELITE KIT The Binding Site, Ltd. | DFH |
| Oct 26, 2000 | K002564 | SHEEP ANTI-HUMAN KAPPA FREE LIGHT CHAIN IMMUNOFIXATION GRADE KIT The Binding Site, Ltd. | DFH |
| Oct 26, 2000 | K002563 | SHEEP ANTI-HUMAN LAMBDA FREE LIGHT CHAIN IMMUNOFIXATION GRADE KIT The Binding Site, Ltd. | DEH |
Newest 50 of 125.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 21, 2003 | Binding Site Inc The Bindazyme, Human AntiCardiolipin IgM Enzyme Immunoassay Kits, MK029 Terminated |
MID | K983694 |