Phadia US, Inc. - FDA 510(k) Cleared Devices
22
Total
21
Cleared
1
Denied
22 devices
Cleared
Feb 13, 2015
ELIA M2
Immunology
262d
Cleared
Oct 27, 2014
ELIA PR3S IMMUNOASSAY, ELIA MPOS IMMUNOASSAY, ELIA GBM IMMUNOASSAY, ELIA...
Immunology
271d
Cleared
Aug 29, 2014
EIA SMDP IMMUNOASSAY
Immunology
372d
Cleared
Dec 23, 2013
ELIA(TM) CARDIOLIPIN IGA IMMUNOASSAY
Immunology
186d
Cleared
Aug 28, 2013
AUTOMATED IN VITRO QUANTITATIVE ASSAY FOR THE MEASUREMENT OF ALLERGEN...
Immunology
400d
Cleared
Sep 13, 2012
IMMUNOCAP ALLERGEN COMPONENTS BUNDLE
Immunology
260d
Cleared
Jun 22, 2012
ELIA B2-GLYCOPROTEIN I IGA IMMUNOASSAY
Immunology
305d
Not Cleared
Feb 15, 2012
IMMUNOCAP TRYPTASE, CALIBRATORS, CURVE CONTROL, CONJUGATE 50, CALIBRATOR...
Immunology
34d
Cleared
Dec 22, 2011
IMMUNOCAP SPECIFIC IGE ALLERGEN BUNDLE, 12 ALLERGEN COMPONENTS
Immunology
168d
Cleared
Sep 30, 2011
RHEUMATOID FACTOR IMMUNOLOGICAL TEST SYSTEM
Immunology
379d
Cleared
Aug 13, 2010
ELIA GLIADIN DP IGA IMMUNOASSAY AND ELIA GLIADIN DP IGG IMMUNOASSAY, MODELS...
Immunology
280d
Cleared
Jun 07, 2010
CARDIOLIPIN AUTOANTIBODY IMMUNOLOGICAL TEST SYSTEM
Immunology
350d
Cleared
Jan 19, 2010
IMMUNOCAP RAPID READER, MODEL 12-3600-10
Immunology
113d
Cleared
May 28, 2009
ELIA RNP70 IMMUNOASSAY, ELIA SCI-70 IMMUNOASSAY AND ELIA JO-1 IMMUNOASSAY,...
Immunology
218d
Cleared
Apr 10, 2009
ELIA CENP IMMUNOASSAY, ELIA U1RNP IMMUNOASSAY, ELIA SM IMMUNOASSAY, ELIA RO...
Immunology
200d
Cleared
Mar 13, 2009
VARELISA RECOMBI ANA SCREEN, MODEL 12 596
Immunology
135d
Cleared
Jan 15, 2008
ELIA SYMPHONY IMMUNOASSAY, ANA CONTROL, MODEL 14-55508-01,83-1004-01
Immunology
165d
Cleared
Dec 07, 2007
ELIA DSDNA IMMUNOASSAY, MODEL 14-5500-01, ELIA ANA CONTROL, MODEL 83-1004-01
Immunology
102d
Cleared
Nov 20, 2007
IMMUNOCAP THYRLOBULIN IMMUNOCAP
Immunology
60d
Cleared
Mar 14, 2007
ELIA GLIADIN IGA, IGG AND CELIAC CONTROL
Immunology
83d
Cleared
Dec 29, 2006
ELIA CELIKEY IGA WELL, MODEL 14-5517-01
Immunology
102d
Cleared
Dec 26, 2006
ELIA CELIKEY IGG WELL, MODEL 14-5518-01, ELIA CELIAC CONTROL, MODEL 83-1011-01
Immunology
116d