The Binding Site, Ltd. - FDA 510(k) Cleared Devices
Recent clearances: Optilite® Freelite® Kappa Free Kit, Optilite® Freelite® Lambda Free Kit
115
Total
115
Cleared
0
Denied
FDA 510(k) Regulatory Record - The Binding Site, Ltd. Immunology ✕
108 devices
Cleared
Jan 24, 2024
Optilite® Freelite® Kappa Free Kit, Optilite® Freelite® Lambda Free Kit
Immunology
265d
Cleared
Dec 30, 2009
HUMAN IGG SUBCLASS LIQUID REAGENT KITS (FOR USE ON HITACHI 911/ 912/ 917 AND...
Immunology
273d
Cleared
May 06, 2009
HUMAN BETA-2 MICROGLOBULIN KIT
Immunology
180d
Cleared
Feb 10, 2009
HUMAN IGM LIQUID REAGENT KIT FOR USE ON THE SPAPLUS ANALYZER
Immunology
196d
Cleared
Dec 19, 2008
HUMAN IGA LIQUID REAGENT KIT FOR USE ON SPAPLUS
Immunology
175d
Cleared
Oct 15, 2008
BINDAZYME HUMAN ANTI-GLIADIN (MGP), IGG EIA KIT
Immunology
120d
Cleared
Feb 01, 2008
HUMAN IGG SUBCLASS LIQUID REAGENT KITS FOR USE ON THE SPAPLUS ANALYSER
Immunology
114d
Cleared
Nov 30, 2007
FREELITE HUMAN KAPPA AND LAMBDA FREE DIAGNOSTIC TEST KITS FOR USE ON THE...
Immunology
242d
Cleared
Jun 21, 2007
FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE SPAPLUS ANALYZER
Immunology
311d
Cleared
Nov 21, 2006
FARRZYME HUMAN HIGH AVIDITY ANTI-DSDNA ENZYME IMMUNOASSAY KIT
Immunology
113d
Cleared
Nov 23, 2005
IGD DIAGNOSTIC TEST KITS
Immunology
189d
Cleared
Sep 06, 2005
FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE BAYER ADVIA 1650...
Immunology
53d
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