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

Phadia US, Inc. has 21 FDA 510(k) cleared immunology devices. Based in Portae, US.

Historical record: 21 cleared submissions from 2006 to 2015.

Browse the complete list of FDA 510(k) cleared immunology devices from this manufacturer. Filter by specialty or product code using the sidebar.

FDA 510(k) Regulatory Record - Phadia US, Inc.
22 devices
1-22 of 22
Cleared Feb 13, 2015
ELIA M2
K141375 · DBM
Immunology · 262d
Cleared Oct 27, 2014
ELIA PR3S IMMUNOASSAY, ELIA MPOS IMMUNOASSAY, ELIA GBM IMMUNOASSAY, ELIA...
K140225 · MOB
Immunology · 271d
Cleared Aug 29, 2014
EIA SMDP IMMUNOASSAY
K132631 · LKP
Immunology · 372d
Cleared Dec 23, 2013
ELIA(TM) CARDIOLIPIN IGA IMMUNOASSAY
K131821 · MID
Immunology · 186d
Cleared Aug 28, 2013
AUTOMATED IN VITRO QUANTITATIVE ASSAY FOR THE MEASUREMENT OF ALLERGEN...
K122197 · DHB
Immunology · 400d
Cleared Sep 13, 2012
IMMUNOCAP ALLERGEN COMPONENTS BUNDLE
K113841 · DHB
Immunology · 260d
Cleared Jun 22, 2012
ELIA B2-GLYCOPROTEIN I IGA IMMUNOASSAY
K112414 · MSV
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
K111919 · DHB
Immunology · 168d
Cleared Sep 30, 2011
RHEUMATOID FACTOR IMMUNOLOGICAL TEST SYSTEM
K102673 · DHR
Immunology · 379d
Cleared Aug 13, 2010
ELIA GLIADIN DP IGA IMMUNOASSAY AND ELIA GLIADIN DP IGG IMMUNOASSAY, MODELS...
K093459 · MST
Immunology · 280d
Cleared Jun 07, 2010
CARDIOLIPIN AUTOANTIBODY IMMUNOLOGICAL TEST SYSTEM
K091845 · MID
Immunology · 350d
Cleared Jan 19, 2010
IMMUNOCAP RAPID READER, MODEL 12-3600-10
K092978 · DHB
Immunology · 113d
Cleared May 28, 2009
ELIA RNP70 IMMUNOASSAY, ELIA SCI-70 IMMUNOASSAY AND ELIA JO-1 IMMUNOASSAY,...
K083117 · LKO
Immunology · 218d
Cleared Apr 10, 2009
ELIA CENP IMMUNOASSAY, ELIA U1RNP IMMUNOASSAY, ELIA SM IMMUNOASSAY, ELIA RO...
K082759 · LKJ
Immunology · 200d
Cleared Mar 13, 2009
VARELISA RECOMBI ANA SCREEN, MODEL 12 596
K083188 · LJM
Immunology · 135d
Cleared Jan 15, 2008
ELIA SYMPHONY IMMUNOASSAY, ANA CONTROL, MODEL 14-55508-01,83-1004-01
K072149 · LLL
Immunology · 165d
Cleared Dec 07, 2007
ELIA DSDNA IMMUNOASSAY, MODEL 14-5500-01, ELIA ANA CONTROL, MODEL 83-1004-01
K072393 · LSW
Immunology · 102d
Cleared Nov 20, 2007
IMMUNOCAP THYRLOBULIN IMMUNOCAP
K072661 · JNL
Immunology · 60d
Cleared Mar 14, 2007
ELIA GLIADIN IGA, IGG AND CELIAC CONTROL
K063775 · MST
Immunology · 83d
Cleared Dec 29, 2006
ELIA CELIKEY IGA WELL, MODEL 14-5517-01
K062787 · MVM
Immunology · 102d
Cleared Dec 26, 2006
ELIA CELIKEY IGG WELL, MODEL 14-5518-01, ELIA CELIAC CONTROL, MODEL 83-1011-01
K062583 · MVM
Immunology · 116d
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