The Binding Site
San Diego, CA, US
THE BINDING SITE appears in FDA device records in San Diego, CA. FDA records list 125 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show one recall for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
Showing 50 of 125FDA records hold 125 510(k) clearances for The Binding Site between 1988 and 2024. The busiest year on record is 1999, with 17. The most recent is 2024, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1988 | 4 |
| 1989 | 1 |
| 1990 | 1 |
| 1991 | 11 |
| 1992 | 6 |
| 1993 | 8 |
| 1994 | 2 |
| 1995 | 1 |
| 1996 | 5 |
| 1997 | 3 |
| 1998 | 6 |
| 1999 | 17 |
| 2000 | 12 |
| 2001 | 14 |
| 2002 | 3 |
| 2003 | 6 |
| 2004 | 5 |
| 2005 | 3 |
| 2006 | 1 |
| 2007 | 2 |
| 2008 | 5 |
| 2009 | 4 |
| 2010 | 1 |
| 2012 | 1 |
| 2013 | 1 |
| 2014 | 1 |
| 2024 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K231290 | Optilite® Freelite® Kappa Free Kit, Optilite® Freelite® Lambda Free Kit | DFH | Substantially Equivalent | |
| K140105 | HEVYLITE HUMAN IGA KAPPA KIT FOR USE ON SIEMENS BNII, HEVYLITE HUMAN IGA LAMBDA KIT FOR USE ON SIEMENS BNII | OPX | Substantially Equivalent | |
| K132555 | HEVYLITE HUMAN IGG KAPPA KIT AND HEVYLITE HUMAN IGG LAMBDA KIT | PCN | Substantially Equivalent | |
| K103824 | HUMAN IGA LIQUID REAGENT KIT FOR USE ON SPA PLUS | CFN | Substantially Equivalent | |
| K100455 | SPAPLUS ANALYZER | DBI | Substantially Equivalent | |
| K090920 | HUMAN IGG SUBCLASS LIQUID REAGENT KITS (FOR USE ON HITACHI 911/ 912/ 917 AND MODULAR P) | CFN | Substantially Equivalent | |
| K092450 | HUMAN IGD KIT FOR USE ON SPAPLUS | CZJ | Substantially Equivalent | |
| K083289 | HUMAN BETA-2 MICROGLOBULIN KIT | JZG | Substantially Equivalent | |
| K082129 | HUMAN IGM LIQUID REAGENT KIT FOR USE ON THE SPAPLUS ANALYZER | CFN | Substantially Equivalent | |
| K081827 | HUMAN IGA LIQUID REAGENT KIT FOR USE ON SPAPLUS | CFN | Substantially Equivalent | |
| K081674 | BINDAZYME HUMAN ANTI-GLIADIN (MGP), IGG EIA KIT; BINDAZYME HUMAN ANTI-GLIADIN (MGP) IGA EIA KIT; (IGA OR IGG) | MST | Substantially Equivalent | |
| K080384 | HUMAN CYSTATIN C KIT FOR USE ON MODULAR P ANALYSER | NDY | Substantially Equivalent | |
| K072889 | HUMAN IGG SUBCLASS LIQUID REAGENT KITS FOR USE ON THE SPAPLUS ANALYSER | CFN | Substantially Equivalent | |
| K072166 | CYSTATIN C KIT FOR USE ON THE SPAPLUS ANALYZER | NDY | Substantially Equivalent | |
| 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 | |
| K062372 | FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE SPAPLUS ANALYZER | DFH | Substantially Equivalent | |
| K062183 | FARRZYME HUMAN HIGH AVIDITY ANTI-DSDNA ENZYME IMMUNOASSAY KIT | LRM | Substantially Equivalent | |
| K051299 | IGD DIAGNOSTIC TEST KITS | CZJ | Substantially Equivalent | |
| K051915 | FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE BAYER ADVIA 1650 ANALYZER | DFH | Substantially Equivalent | |
| K042579 | BINDAZYME HUMAN ASCA IGG AND IGA EIA DIAGNOSTIC TEST KIT | NBT | Substantially Equivalent | |
| K042152 | BINDING SITE IGG SUBLCASS OLYMPUS KITS | CFN | Substantially Equivalent | |
| K041891 | MININEPH HUMAN RHEUMATOID FACTOR KIT | DHR | Substantially Equivalent | |
| K040466 | BINDAZYME HUMAN ANTI TISSUE TRANSGLUTAMINASE IGA AND IGG EIA DIAGNOSTIC TEST KITS | MVM | Substantially Equivalent | |
| K040009 | FREELITE HUMAN KAPPA AND LAMBDA KITS | DFH | Substantially Equivalent | |
| K033811 | FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE OLYMPUS AU ANALYZER | DEH | Substantially Equivalent | |
| K032240 | BINDAZYME HUMAN ANTI-PHOSPHATIDYLSERINE IGA, IGG AND IGM ENZYME IMMUNOASSAY KIT | MID | Substantially Equivalent | |
| K031563 | BINDAZYME CLQ CIC EIA KIT | DAK | Substantially Equivalent | |
| K031016 | FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE DAD BEHRING NEPHELOMETER II | DEH | Substantially Equivalent | |
| K030238 | BINDAZYME ANTI-MITOCHONDRIA M2 IGGAM EIA KIT | DBM | Substantially Equivalent | |
| K023131 | FREELITE HUMAN LAMBDA FREE KIT | DEH | Substantially Equivalent | |
| K023009 | FREELITE HUMAN KAPPA AND HUMAN LAMBDA FREE KITS FOR USE ON THE HITACHI 911/912 ANALYZER | DFH | Substantially Equivalent | |
| K014270 | MININEPH HUMAN B2-MICROGLOBULIN KIT | JZG | Substantially Equivalent | |
| K022083 | HUMAN IGG SUBCLASS KIT FOR USE ON THE BECKMAN IMMAGE ANALYSER | CFN | Substantially Equivalent | |
| K021081 | HUMAN IGG SUBCLASS LIQUID REAGENT KITS FOR USE ON THE HITACHI 911/7070 TURBIDIMETRIC ANALYSER | DFZ | Substantially Equivalent | |
| K012296 | HUMAN IGG SUBCLASS LIQUID REAGENT KITS, PRODUCT CODE LK001.T | CFN | Substantially Equivalent | |
| K012292 | HUMAN IGG SUBCLASS LIQUID REAGENT KITS, PRODUCT CODE LK001.TB | CFN | Substantially Equivalent | |
| K012295 | HUMAN IGG SUBCLASS LIQUID REAGENT KITS, PRODUCT CODE NK001.T | CFN | Substantially Equivalent | |
| K012291 | HUMAN IGG SUBCLASS LIQUID REAGENT KITS, PRODUCT CODE LK001.TA | CFN | Substantially Equivalent | |
| K011663 | MININEPH A-1 ANTITRYPSIN ANTISERUM, HIGH AND LOW SERUM CONTROLS | DEM | Substantially Equivalent | |
| K011662 | MININEPH A-1 TRANSFERRIN ANTISERUM, HIGH AND LOW SERUM CONTROL | DDG | Substantially Equivalent | |
| K010441 | FREELITE KAPPA FREE KIT | DEH | Substantially Equivalent | |
| K010440 | FREELITE LAMBDA FREE KIT | DEH | Substantially Equivalent | |
| K010147 | ENA EIA KIT | LLL | Substantially Equivalent | |
| K010146 | ENA EIA KIT RANGE | LLL | Substantially Equivalent | |
| K010148 | ENA SCREEN EIA KIT | LLL | Substantially Equivalent | |
| K004019 | ANA EIA DIAGNOSTIC TEST KIT | LJM | Substantially Equivalent | |
| K003671 | LAMBDA IMMAGE FREELITE KIT | DEH | Substantially Equivalent | |
| K003669 | KAPPA IMMAGE FREELITE KIT | DFH | Substantially Equivalent | |
| K002564 | SHEEP ANTI-HUMAN KAPPA FREE LIGHT CHAIN IMMUNOFIXATION GRADE KIT | DFH | Substantially Equivalent | |
| K002563 | SHEEP ANTI-HUMAN LAMBDA FREE LIGHT CHAIN IMMUNOFIXATION GRADE KIT | DEH | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3012471076 | 3012471076 | THE BINDING SITE | Unit 27-29, 31-33 Sovereign Road, Kings Norton Birmingham B30 3HN GB | 2026 | and 40 more, listed in full below |
| 2083566 | 2083566 | THE BINDING SITE, INC. | 9606 Kearny Villa Rd, SAN DIEGO, CA 92126 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- DCFAlbumin, Antigen, Antiserum, Control
- LKLAlpha-1-Acid-Glycoprotein, Antigen, Antiserum, Control
- DEMAlpha-1-Antitrypsin, Antigen, Antiserum, Control
- DEBAlpha-2-Macroglobulin, Antigen, Antiserum, Control
- JJEAnalyzer, Chemistry (Photometric, Discrete), For Clinical Use
- LRMAnti-Dna Antibody (Enzyme-Labeled), Antigen, Control
- KTLAnti-Dna Indirect Immunofluorescent Solid Phase
- DBMAntimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control
- LJMAntinuclear Antibody (Enzyme-Labeled), Antigen, Controls
- DHNAntinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
- GRPAntisera, All Types, H. Influenza
- GOSAntiserum, Fluorescent, C. Diphtheriae
- GTQAntistreptolysin - Titer/Streptolysin O Reagent
- JBQAntithrombin Iii Quantitation
- JJNApparatus, Electrophoresis, For Clinical Use
- DCKC-Reactive Protein, Antigen, Antiserum, And Control
- JIXCalibrator, Multi-Analyte Mixture
- JISCalibrator, Primary
- JITCalibrator, Secondary
- DDBCeruloplasmin, Antigen, Antiserum, Control
- DBAComplement C1 Inhibitor (Inactivator), Antigen, Antiserum, Control
- DAKComplement C1q, Antigen, Antiserum, Control
- CZWComplement C3, Antigen, Antiserum, Control
- DBIComplement C4, Antigen, Antiserum, Control
- DAYComplement C5, Antigen, Antiserum, Control
- DAEComplement C9, Antigen, Antiserum, Control
- JRICuvette, Thermostated
- JCBDetergent
- CEFElectrophoretic, Protein Fractionation
- LLLExtractable Antinuclear Antibody, Antigen And Control
- DADHaptoglobin, Antigen, Antiserum, Control
- DABHaptoglobin, Fitc, Antigen, Antiserum, Control
- CZPIga, Antigen, Antiserum, Control
- CZJIgd, Antigen, Antiserum, Control
- DGCIge, Antigen, Antiserum, Control
- DGOIge, Peroxidase, Antigen, Antiserum, Control
- DASIgg (Fc Fragment Specific), Antigen, Antiserum, Control
- DFZIgg (Gamma Chain Specific), Antigen, Antiserum, Control
- CFFImmunoelectrophoretic, Immunoglobulins, (G, A, M)
- DFHKappa, Antigen, Antiserum, Control
- DEHLambda, Antigen, Antiserum, Control
- CFNMethod, Nephelometric, Immunoglobulins (G, A, M)
- JJYMulti-Analyte Controls, All Kinds (Assayed)
- DBLMultiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control
- DDXPlasminogen, Antigen, Antiserum, Control
- JZQPlates And Equipment, Radial Immunodiffusion
- JZJPrealbumin, Antigen, Antiserum, Control
- CFQRadioimmunoassay, Immunoglobulins (G, A, M)
- CZSRetinol-Binding Protein, Antigen, Antiserum, Control
- JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)
- KQJSystem, Fibrinogen Determination
- MIDSystem, Test, Anticardiolipin Immunological
- JZGSystem, Test, Beta-2-Microglobulin Immunological
- DCNSystem, Test, C-Reactive Protein
- DHRSystem, Test, Rheumatoid Factor
- DHCSystem, Test, Systemic Lupus Erythematosus
- JZOSystem, Test, Thyroid Autoantibody
- GGPTest, Qualitative And Quantitative Factor Deficiency
- DFITotal Spinal-Fluid, Antigen, Antiserum, Control
- DDGTransferrin, Antigen, Antiserum, Control
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0950-03 | Bindazyme, Human AntiCardiolipin IgM Enzyme Immunoassay Kits, MK029 | Risk of false positives. | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain