FDA 510(k) Applications Submitted by PHADIA US INC.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K141375 |
05/27/2014 |
ELIA M2; IMMUNOASSAY, POSITIVE CONTROL 100, POSITIVE CONTROL 250 |
PHADIA US INC. |
| DEN120001 |
01/12/2012 |
IMMUNOCAP TRYPTASE, CALIBRATORS, CURVE CONTROL, CONJUGATE 50, CALIBRATOR STRIP, CURVE CONTROL STRIP, ANTI-TRYPTASE |
PHADIA US INC. |
| K140225 |
01/29/2014 |
ELIA PR3S IMMUNOASSAY, ELIA MPOS IMMUNOASSAY, ELIA GBM IMMUNOASSAY, ELIA ANCA/GBM POSITIVE CONTROL 100, ELIA ANCA/GBM PO |
PHADIA US INC. |
| K111919 |
07/07/2011 |
IMMUNOCAP SPECIFIC IGE ALLERGEN BUNDLE, 12 ALLERGEN COMPONENTS |
PHADIA US INC. |
| K122197 |
07/24/2012 |
AUTOMATED IN VITRO QUANTITATIVE ASSAY FOR THE MEASUREMENT OF ALLERGEN SPECIFIC IGE ANTIBODIES |
PHADIA US INC. |
| K072149 |
08/03/2007 |
ELIA SYMPHONY IMMUNOASSAY, ANA CONTROL, MODEL 14-55508-01,83-1004-01 |
PHADIA US INC. |
| K092978 |
09/28/2009 |
IMMUNOCAP RAPID READER, MODEL 12-3600-10 |
PHADIA US INC. |
| K113841 |
12/28/2011 |
IMMUNOCAP ALLERGEN COMPONENTS BUNDLE |
PHADIA US INC. |
| K112414 |
08/22/2011 |
ELIA B2-GLYCOPROTEIN I IGA IMMUNOASSAY |
PHADIA US INC. |
| K132631 |
08/22/2013 |
EIA SMDP IMMUNOASSAY |
PHADIA US INC. |
| K083117 |
10/22/2008 |
ELIA RNP70 IMMUNOASSAY, ELIA SCI-70 IMMUNOASSAY AND ELIA JO-1 IMMUNOASSAY, MODELS 14-5511-01, 14-5506-01 AND 14-5507-01 |
PHADIA US INC. |
| K093459 |
11/06/2009 |
ELIA GLIADIN DP IGA IMMUNOASSAY AND ELIA GLIADIN DP IGG IMMUNOASSAY, MODELS 14-5538-01, 14-5539-01 |
PHADIA US INC. |
| K102673 |
09/16/2010 |
RHEUMATOID FACTOR IMMUNOLOGICAL TEST SYSTEM |
PHADIA US INC. |
| K131821 |
06/20/2013 |
ELIA(TM) CARDIOLIPIN IGA IMMUNOASSAY |
PHADIA US INC. |
| K072393 |
08/27/2007 |
ELIA DSDNA IMMUNOASSAY, MODEL 14-5500-01, ELIA ANA CONTROL, MODEL 83-1004-01 |
PHADIA US INC. |
| K062583 |
09/01/2006 |
ELIA CELIKEY IGG WELL, MODEL 14-5518-01, ELIA CELIAC CONTROL, MODEL 83-1011-01 |
PHADIA US INC. |
| K062787 |
09/18/2006 |
ELIA CELIKEY IGA WELL, MODEL 14-5517-01; ELIA CELIAC CONTROL, MODEL 83-1011-01 |
PHADIA US INC. |
| K072661 |
09/21/2007 |
IMMUNOCAP THYRLOBULIN IMMUNOCAP |
PHADIA US INC. |
| K082759 |
09/22/2008 |
ELIA CENP IMMUNOASSAY, ELIA U1RNP IMMUNOASSAY, ELIA SM IMMUNOASSAY, ELIA RO IMMUNOASSAY |
PHADIA US INC. |
| K083188 |
10/29/2008 |
VARELISA RECOMBI ANA SCREEN, MODEL 12 596 |
PHADIA US INC. |
| K063775 |
12/21/2006 |
ELIA GLIADIN IGA, IGG AND CELIAC CONTROL |
PHADIA US INC. |
| K091845 |
06/22/2009 |
CARDIOLIPIN AUTOANTIBODY IMMUNOLOGICAL TEST SYSTEM |
PHADIA US INC. |
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