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FDA 510(k) Applications Submitted by THE BINDING SITE
FDA 510(k) Number
Submission Date
Device Name
Applicant
K100455
02/17/2010
SPAPLUS ANALYZER
THE BINDING SITE
K072166
08/06/2007
CYSTATIN C KIT FOR USE ON THE SPAPLUS ANALYZER
THE BINDING SITE
K092450
08/10/2009
HUMAN IGD KIT FOR USE ON SPAPLUS
THE BINDING SITE
K040466
02/23/2004
BINDAZYME HUMAN ANTI TISSUE TRANSGLUTAMINASE IGA AND IGG EIA DIAGNOSTIC TEST KITS
THE BINDING SITE
K041891
07/12/2004
MININEPH HUMAN RHEUMATOID FACTOR KIT
THE BINDING SITE
K042152
08/09/2004
BINDING SITE IGG SUBLCASS OLYMPUS KITS
THE BINDING SITE
K042579
09/22/2004
BINDAZYME HUMAN ASCA IGG AND IGA EIA DIAGNOSTIC TEST KIT
THE BINDING SITE
K140105
01/15/2014
HEVYLITE HUMAN IGA KAPPA KIT FOR USE ON SIEMENS BNII, HEVYLITE HUMAN IGA LAMBDA KIT FOR USE ON SIEMENS BNII
THE BINDING SITE
K132555
08/14/2013
HEVYLITE HUMAN IGG KAPPA KIT AND HEVYLITE HUMAN IGG LAMBDA KIT
THE BINDING SITE
K103824
12/30/2010
HUMAN IGA LIQUID REAGENT KIT FOR USE ON SPA PLUS
THE BINDING SITE
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