Medical Device Manufacturer · US , Santa Monica , CA

The Binding Site

10 submissions · 10 cleared · Since 2004
10
Total
10
Cleared
0
Denied

The Binding Site — FDA 510(k) Submissions

The Binding Site has submitted 10 FDA 510(k) premarket notifications since 2004, of which 10 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Method, Nephelometric, Immunoglobulins (g, A, M), Immunoglobulin G Kappa Heavy And Light Chain Combined, Immunoglobulin A Kappa Heavy & Light Chain Combined, Autoantibodies, Endomysial(tissue Transglutaminase), System, Test, Rheumatoid Factor . Use the specialty filter in the sidebar to narrow results.

10 devices
1–10 of 10
HEVYLITE HUMAN IGA KAPPA KIT FOR USE ON SIEMENS BNII, HEVYLITE HUMAN IGA LAMBDA KIT FOR USE ON SIEMENS BNII
K140105 · OPX Immunoglobulin A Kappa... · Immunology
Mar 2014 62d
HEVYLITE HUMAN IGG KAPPA KIT AND HEVYLITE HUMAN IGG LAMBDA KIT
K132555 · PCN Immunoglobulin G Kappa... · Immunology
Dec 2013 128d
HUMAN IGA LIQUID REAGENT KIT FOR USE ON SPA PLUS
K103824 · CFN Method, Nephelometric,... · Immunology
Feb 2012 424d
SPAPLUS ANALYZER
K100455 · DBI Complement C4, Antigen,... · Immunology
Sep 2010 198d
HUMAN IGD KIT FOR USE ON SPAPLUS
K092450 · CZJ Igd, Antigen, Antiserum,... · Immunology
Dec 2009 140d
CYSTATIN C KIT FOR USE ON THE SPAPLUS ANALYZER
K072166 · NDY Test, Cystatin C · Chemistry
Jan 2008 171d
BINDAZYME HUMAN ASCA IGG AND IGA EIA DIAGNOSTIC TEST KIT
K042579 · NBT Antibodies, Saccharomyces... · Immunology
Jul 2005 309d
BINDING SITE IGG SUBLCASS OLYMPUS KITS
K042152 · CFN Method, Nephelometric,... · Immunology
Nov 2004 105d
MININEPH HUMAN RHEUMATOID FACTOR KIT
K041891 · DHR System, Test, Rheumatoid... · Immunology
Nov 2004 116d
BINDAZYME HUMAN ANTI TISSUE TRANSGLUTAMINASE IGA AND IGG EIA DIAGNOSTIC TEST KITS
K040466 · MVM Autoantibodies,... · Immunology
Jul 2004 144d
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