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Phadia US, Inc.

22 FDA 510(k) clearances · Manufacturer

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RecordFirmDate
ELIA M2; IMMUNOASSAY, POSITIVE CONTROL 100, POSITIVE CONTROL 250 (K141375)Phadia US, Inc.2015-02-13
ELIA PR3S IMMUNOASSAY, ELIA MPOS IMMUNOASSAY, ELIA GBM IMMUNOASSAY, ELIA ANCA/GBM POSITIVE CONTROL 100, ELIA ANCA/GBM PO (K140225)Phadia US, Inc.2014-10-27
EIA SMDP IMMUNOASSAY (K132631)Phadia US, Inc.2014-08-29
ELIA(TM) CARDIOLIPIN IGA IMMUNOASSAY (K131821)Phadia US, Inc.2013-12-23
AUTOMATED IN VITRO QUANTITATIVE ASSAY FOR THE MEASUREMENT OF ALLERGEN SPECIFIC IGE ANTIBODIES (K122197)Phadia US, Inc.2013-08-28
IMMUNOCAP ALLERGEN COMPONENTS BUNDLE (K113841)Phadia US, Inc.2012-09-13
ELIA B2-GLYCOPROTEIN I IGA IMMUNOASSAY (K112414)Phadia US, Inc.2012-06-22
IMMUNOCAP TRYPTASE, CALIBRATORS, CURVE CONTROL, CONJUGATE 50, CALIBRATOR STRIP, CURVE CONTROL STRIP, ANTI-TRYPTASE (DEN120001)Phadia US, Inc.2012-02-15
IMMUNOCAP SPECIFIC IGE ALLERGEN BUNDLE, 12 ALLERGEN COMPONENTS (K111919)Phadia US, Inc.2011-12-22
RHEUMATOID FACTOR IMMUNOLOGICAL TEST SYSTEM (K102673)Phadia US, Inc.2011-09-30
ELIA GLIADIN DP IGA IMMUNOASSAY AND ELIA GLIADIN DP IGG IMMUNOASSAY, MODELS 14-5538-01, 14-5539-01 (K093459)Phadia US, Inc.2010-08-13
CARDIOLIPIN AUTOANTIBODY IMMUNOLOGICAL TEST SYSTEM (K091845)Phadia US, Inc.2010-06-07
IMMUNOCAP RAPID READER, MODEL 12-3600-10 (K092978)Phadia US, Inc.2010-01-19
ELIA RNP70 IMMUNOASSAY, ELIA SCI-70 IMMUNOASSAY AND ELIA JO-1 IMMUNOASSAY, MODELS 14-5511-01, 14-5506-01 AND 14-5507-01 (K083117)Phadia US, Inc.2009-05-28
ELIA CENP IMMUNOASSAY, ELIA U1RNP IMMUNOASSAY, ELIA SM IMMUNOASSAY, ELIA RO IMMUNOASSAY (K082759)Phadia US, Inc.2009-04-10
VARELISA RECOMBI ANA SCREEN, MODEL 12 596 (K083188)Phadia US, Inc.2009-03-13
ELIA SYMPHONY IMMUNOASSAY, ANA CONTROL, MODEL 14-55508-01,83-1004-01 (K072149)Phadia US, Inc.2008-01-15
ELIA DSDNA IMMUNOASSAY, MODEL 14-5500-01, ELIA ANA CONTROL, MODEL 83-1004-01 (K072393)Phadia US, Inc.2007-12-07
IMMUNOCAP THYRLOBULIN IMMUNOCAP (K072661)Phadia US, Inc.2007-11-20
ELIA GLIADIN IGA, IGG AND CELIAC CONTROL (K063775)Phadia US, Inc.2007-03-14
ELIA CELIKEY IGA WELL, MODEL 14-5517-01; ELIA CELIAC CONTROL, MODEL 83-1011-01 (K062787)Phadia US, Inc.2006-12-29
ELIA CELIKEY IGG WELL, MODEL 14-5518-01, ELIA CELIAC CONTROL, MODEL 83-1011-01 (K062583)Phadia US, Inc.2006-12-26

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Every clearance here is in the API, with alerts when new ones post.