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FDA 510(k) & PMA Approved Devices — 115 products

Total Devices115
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K231290 Optilite® Freelite® Kappa Free Kit, Optilite® Freelite® Lambda Free KitDFH2024-01-24 View
510(k) K090920 HUMAN IGG SUBCLASS LIQUID REAGENT KITS (FOR USE ON HITACHI 911/ 912/ 917 AND MODULAR P)CFN2009-12-30 View
510(k) K083289 HUMAN BETA-2 MICROGLOBULIN KITJZG2009-05-06 View
510(k) K082129 HUMAN IGM LIQUID REAGENT KIT FOR USE ON THE SPAPLUS ANALYZERCFN2009-02-10 View
510(k) K081827 HUMAN IGA LIQUID REAGENT KIT FOR USE ON SPAPLUSCFN2008-12-19 View
510(k) K081674 BINDAZYME HUMAN ANTI-GLIADIN (MGP), IGG EIA KIT; BINDAZYME HUMAN ANTI-GLIADIN (MGP) IGA EIA KIT; (IGA OR IGG)MST2008-10-15 View
510(k) K080384 HUMAN CYSTATIN C KIT FOR USE ON MODULAR P ANALYSERNDY2008-06-06 View
510(k) K072889 HUMAN IGG SUBCLASS LIQUID REAGENT KITS FOR USE ON THE SPAPLUS ANALYSERCFN2008-02-01 View
510(k) K070900 FREELITE HUMAN KAPPA AND LAMBDA FREE DIAGNOSTIC TEST KITS FOR USE ON THE ROCHE COBAS INTEGRA 400/400 PLUS ANALYZER KITDFH2007-11-30 View
510(k) K062372 FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE SPAPLUS ANALYZERDFH2007-06-21 View
510(k) K062183 FARRZYME HUMAN HIGH AVIDITY ANTI-DSDNA ENZYME IMMUNOASSAY KITLRM2006-11-21 View
510(k) K051299 IGD DIAGNOSTIC TEST KITSCZJ2005-11-23 View
510(k) K051915 FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE BAYER ADVIA 1650 ANALYZERDFH2005-09-06 View
510(k) K040009 FREELITE HUMAN KAPPA AND LAMBDA KITSDFH2004-03-11 View
510(k) K033811 FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE OLYMPUS AU ANALYZERDEH2004-01-30 View
510(k) K032240 BINDAZYME HUMAN ANTI-PHOSPHATIDYLSERINE IGA, IGG AND IGM ENZYME IMMUNOASSAY KITMID2003-09-29 View
510(k) K031563 BINDAZYME CLQ CIC EIA KITDAK2003-09-10 View
510(k) K031016 FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE DAD BEHRING NEPHELOMETER IIDEH2003-07-15 View
510(k) K030238 BINDAZYME ANTI-MITOCHONDRIA M2 IGGAM EIA KITDBM2003-03-24 View
510(k) K023131 FREELITE HUMAN LAMBDA FREE KITDEH2003-01-21 View
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