Phadia US, Inc. - FDA 510(k) Cleared Devices
Recent clearances: ELIA M2, ELIA PR3S IMMUNOASSAY, ELIA MPOS IMMUNOASSAY, ELIA GBM IMMUNOASSAY, ELIA ANCA/GBM POSITIVE CONTROL 100, ELIA ANCA/GBM PO, EIA SMDP IMMUNOASSAY
22
Total
21
Cleared
1
Denied
FDA 510(k) Regulatory Record - Phadia US, Inc. Immunology ✕
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