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Phadia US, Inc.

FDA 510(k) & PMA Approved Devices — 18 products

Total Devices18
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K131821 ELIA(TM) CARDIOLIPIN IGA IMMUNOASSAYMID2013-12-23 View
510(k) K122197 AUTOMATED IN VITRO QUANTITATIVE ASSAY FOR THE MEASUREMENT OF ALLERGEN SPECIFIC IGE ANTIBODIESDHB2013-08-28 View
510(k) K113841 IMMUNOCAP ALLERGEN COMPONENTS BUNDLEDHB2012-09-13 View
510(k) K112414 ELIA B2-GLYCOPROTEIN I IGA IMMUNOASSAYMSV2012-06-22 View
510(k) K111919 IMMUNOCAP SPECIFIC IGE ALLERGEN BUNDLE, 12 ALLERGEN COMPONENTSDHB2011-12-22 View
510(k) K102673 RHEUMATOID FACTOR IMMUNOLOGICAL TEST SYSTEMDHR2011-09-30 View
510(k) K093459 ELIA GLIADIN DP IGA IMMUNOASSAY AND ELIA GLIADIN DP IGG IMMUNOASSAY, MODELS 14-5538-01, 14-5539-01MST2010-08-13 View
510(k) K091845 CARDIOLIPIN AUTOANTIBODY IMMUNOLOGICAL TEST SYSTEMMID2010-06-07 View
510(k) K092978 IMMUNOCAP RAPID READER, MODEL 12-3600-10DHB2010-01-19 View
510(k) K083117 ELIA RNP70 IMMUNOASSAY, ELIA SCI-70 IMMUNOASSAY AND ELIA JO-1 IMMUNOASSAY, MODELS 14-5511-01, 14-5506-01 AND 14-5507-01LKO2009-05-28 View
510(k) K082759 ELIA CENP IMMUNOASSAY, ELIA U1RNP IMMUNOASSAY, ELIA SM IMMUNOASSAY, ELIA RO IMMUNOASSAYLKJ2009-04-10 View
510(k) K083188 VARELISA RECOMBI ANA SCREEN, MODEL 12 596LJM2009-03-13 View
510(k) K072149 ELIA SYMPHONY IMMUNOASSAY, ANA CONTROL, MODEL 14-55508-01,83-1004-01LLL2008-01-15 View
510(k) K072393 ELIA DSDNA IMMUNOASSAY, MODEL 14-5500-01, ELIA ANA CONTROL, MODEL 83-1004-01LSW2007-12-07 View
510(k) K072661 IMMUNOCAP THYRLOBULIN IMMUNOCAPJNL2007-11-20 View
510(k) K063775 ELIA GLIADIN IGA, IGG AND CELIAC CONTROLMST2007-03-14 View
510(k) K062787 ELIA CELIKEY IGA WELL, MODEL 14-5517-01; ELIA CELIAC CONTROL, MODEL 83-1011-01MVM2006-12-29 View
510(k) K062583 ELIA CELIKEY IGG WELL, MODEL 14-5518-01, ELIA CELIAC CONTROL, MODEL 83-1011-01MVM2006-12-26 View
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