Medical Device Manufacturer · US , Los Angeles , CA

The Binding Site, Ltd.

115 submissions · 115 cleared · Since 1988
115
Total
115
Cleared
0
Denied

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

The Binding Site, Ltd. has submitted 115 FDA 510(k) premarket notifications since 1988, of which 115 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, Lambda, Antigen, Antiserum, Control, System, Test, Beta-2-microglobulin Immunological, System, Test, Anticardiolipin Immunological . Use the specialty filter in the sidebar to narrow results.

115 devices
1–25 of 115
Optilite? Freelite? Kappa Free Kit, Optilite? Freelite? Lambda Free Kit
K231290 · DFH Kappa, Antigen,... · Immunology
Jan 2024 265d
HUMAN IGG SUBCLASS LIQUID REAGENT KITS (FOR USE ON HITACHI 911/ 912/ 917 AND MODULAR P)
K090920 · CFN Method, Nephelometric,... · Immunology
Dec 2009 273d
HUMAN BETA-2 MICROGLOBULIN KIT
K083289 · JZG System, Test,... · Immunology
May 2009 180d
HUMAN IGM LIQUID REAGENT KIT FOR USE ON THE SPAPLUS ANALYZER
K082129 · CFN Method, Nephelometric,... · Immunology
Feb 2009 196d
HUMAN IGA LIQUID REAGENT KIT FOR USE ON SPAPLUS
K081827 · CFN Method, Nephelometric,... · Immunology
Dec 2008 175d
BINDAZYME HUMAN ANTI-GLIADIN (MGP), IGG EIA KIT; BINDAZYME HUMAN ANTI-GLIADIN (MGP) IGA EIA KIT; (IGA OR IGG)
K081674 · MST Antibodies, Gliadin · Immunology
Oct 2008 120d
HUMAN CYSTATIN C KIT FOR USE ON MODULAR P ANALYSER
K080384 · NDY Test, Cystatin C · Chemistry
Jun 2008 114d
HUMAN IGG SUBCLASS LIQUID REAGENT KITS FOR USE ON THE SPAPLUS ANALYSER
K072889 · CFN Method, Nephelometric,... · Immunology
Feb 2008 114d
FREELITE HUMAN KAPPA AND LAMBDA FREE DIAGNOSTIC TEST KITS FOR USE ON THE ROCHE COBAS INTEGRA 400/400 PLUS ANALYZER KIT
K070900 · DFH Kappa, Antigen,... · Immunology
Nov 2007 242d
FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE SPAPLUS ANALYZER
K062372 · DFH Kappa, Antigen,... · Immunology
Jun 2007 311d
FARRZYME HUMAN HIGH AVIDITY ANTI-DSDNA ENZYME IMMUNOASSAY KIT
K062183 · LRM Anti-dna Antibody... · Immunology
Nov 2006 113d
IGD DIAGNOSTIC TEST KITS
K051299 · CZJ Igd, Antigen, Antiserum,... · Immunology
Nov 2005 189d
FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE BAYER ADVIA 1650 ANALYZER
K051915 · DFH Kappa, Antigen,... · Immunology
Sep 2005 53d
FREELITE HUMAN KAPPA AND LAMBDA KITS
K040009 · DFH Kappa, Antigen,... · Immunology
Mar 2004 69d
FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE OLYMPUS AU ANALYZER
K033811 · DEH Lambda, Antigen,... · Immunology
Jan 2004 52d
BINDAZYME HUMAN ANTI-PHOSPHATIDYLSERINE IGA, IGG AND IGM ENZYME IMMUNOASSAY KIT
K032240 · MID System, Test,... · Immunology
Sep 2003 70d
BINDAZYME CLQ CIC EIA KIT
K031563 · DAK Complement C1q, Antigen,... · Immunology
Sep 2003 114d
FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE DAD BEHRING NEPHELOMETER II
K031016 · DEH Lambda, Antigen,... · Immunology
Jul 2003 106d
BINDAZYME ANTI-MITOCHONDRIA M2 IGGAM EIA KIT
K030238 · DBM Antimitochondrial... · Immunology
Mar 2003 60d
FREELITE HUMAN KAPPA AND HUMAN LAMBDA FREE KITS FOR USE ON THE HITACHI 911/912 ANALYZER
K023009 · DFH Kappa, Antigen,... · Immunology
Jan 2003 134d
FREELITE HUMAN LAMBDA FREE KIT
K023131 · DEH Lambda, Antigen,... · Immunology
Jan 2003 134d
MININEPH HUMAN B2-MICROGLOBULIN KIT
K014270 · JZG System, Test,... · Immunology
Aug 2002 231d
HUMAN IGG SUBCLASS KIT FOR USE ON THE BECKMAN IMMAGE ANALYSER
K022083 · CFN Method, Nephelometric,... · Immunology
Jul 2002 20d
HUMAN IGG SUBCLASS LIQUID REAGENT KITS FOR USE ON THE HITACHI 911/7070 TURBIDIMETRIC ANALYSER
K021081 · DFZ Igg (gamma Chain... · Immunology
Jun 2002 75d
HUMAN IGG SUBCLASS LIQUID REAGENT KITS, PRODUCT CODE LK001.TB
K012292 · CFN Method, Nephelometric,... · Immunology
Aug 2001 42d

Looking for a specific device from The Binding Site, Ltd.? Search by device name or K-number.

Search all The Binding Site, Ltd. devices
Filters