Medical Device Manufacturer · US , Portae , MI

Phadia US, Inc. - FDA 510(k) Cleared Devices

22 submissions · 21 cleared · Since 2006

22

Total

21

Cleared

1

Denied

FDA 510(k) Regulatory Record - Phadia US, Inc. Immunology ✕

22 devices

1-12 of 22

Cleared Feb 13, 2015

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...

DEN120001 · OYL

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