Medical Device Manufacturer · US , Portae , MI

Phadia US, Inc.

22 submissions · 21 cleared · Since 2006
22
Total
21
Cleared
1
Denied

Phadia US, Inc. — FDA 510(k) Submissions

Phadia US, Inc. has submitted 22 FDA 510(k) premarket notifications since 2006, of which 21 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include System, Test, Radioallergosorbent (rast) Immunological, System, Test, Anticardiolipin Immunological, Autoantibodies, Endomysial(tissue Transglutaminase), Antibodies, Gliadin, Tryptase Assay System . Use the specialty filter in the sidebar to narrow results.

22 devices
1–22 of 22
ELIA M2; IMMUNOASSAY, POSITIVE CONTROL 100, POSITIVE CONTROL 250
K141375 · DBM Antimitochondrial... · Immunology
Feb 2015 262d
ELIA PR3S IMMUNOASSAY, ELIA MPOS IMMUNOASSAY, ELIA GBM IMMUNOASSAY, ELIA ANCA/GBM POSITIVE CONTROL 100, ELIA ANCA/GBM PO
K140225 · MOB Test System,... · Immunology
Oct 2014 271d
EIA SMDP IMMUNOASSAY
K132631 · LKP Anti-sm Antibody, Antigen... · Immunology
Aug 2014 372d
ELIA(TM) CARDIOLIPIN IGA IMMUNOASSAY
K131821 · MID System, Test,... · Immunology
Dec 2013 186d
AUTOMATED IN VITRO QUANTITATIVE ASSAY FOR THE MEASUREMENT OF ALLERGEN SPECIFIC IGE ANTIBODIES
K122197 · DHB System, Test,... · Immunology
Aug 2013 400d
IMMUNOCAP ALLERGEN COMPONENTS BUNDLE
K113841 · DHB System, Test,... · Immunology
Sep 2012 260d
ELIA B2-GLYCOPROTEIN I IGA IMMUNOASSAY
K112414 · MSV System,test,antibodies,b2... · Immunology
Jun 2012 305d
IMMUNOCAP TRYPTASE, CALIBRATORS, CURVE CONTROL, CONJUGATE 50, CALIBRATOR STRIP, CURVE CONTROL STRIP, ANTI-TRYPTASE
DEN120001 · OYL Tryptase Assay System · Immunology
Feb 2012 34d
IMMUNOCAP SPECIFIC IGE ALLERGEN BUNDLE, 12 ALLERGEN COMPONENTS
K111919 · DHB System, Test,... · Immunology
Dec 2011 168d
RHEUMATOID FACTOR IMMUNOLOGICAL TEST SYSTEM
K102673 · DHR System, Test, Rheumatoid... · Immunology
Sep 2011 379d
ELIA GLIADIN DP IGA IMMUNOASSAY AND ELIA GLIADIN DP IGG IMMUNOASSAY, MODELS 14-5538-01, 14-5539-01
K093459 · MST Antibodies, Gliadin · Immunology
Aug 2010 280d
CARDIOLIPIN AUTOANTIBODY IMMUNOLOGICAL TEST SYSTEM
K091845 · MID System, Test,... · Immunology
Jun 2010 350d
IMMUNOCAP RAPID READER, MODEL 12-3600-10
K092978 · DHB System, Test,... · Immunology
Jan 2010 113d
ELIA RNP70 IMMUNOASSAY, ELIA SCI-70 IMMUNOASSAY AND ELIA JO-1 IMMUNOASSAY, MODELS 14-5511-01, 14-5506-01 AND 14-5507-01
K083117 · LKO Anti-rnp Antibody,... · Immunology
May 2009 218d
ELIA CENP IMMUNOASSAY, ELIA U1RNP IMMUNOASSAY, ELIA SM IMMUNOASSAY, ELIA RO IMMUNOASSAY
K082759 · LKJ Antinuclear Antibody,... · Immunology
Apr 2009 200d
VARELISA RECOMBI ANA SCREEN, MODEL 12 596
K083188 · LJM Antinuclear Antibody... · Immunology
Mar 2009 135d
ELIA SYMPHONY IMMUNOASSAY, ANA CONTROL, MODEL 14-55508-01,83-1004-01
K072149 · LLL Extractable Antinuclear... · Immunology
Jan 2008 165d
ELIA DSDNA IMMUNOASSAY, MODEL 14-5500-01, ELIA ANA CONTROL, MODEL 83-1004-01
K072393 · LSW Anti-dna Antibody,... · Immunology
Dec 2007 102d
IMMUNOCAP THYRLOBULIN IMMUNOCAP
K072661 · JNL Immunochemical,... · Immunology
Nov 2007 60d
ELIA GLIADIN IGA, IGG AND CELIAC CONTROL
K063775 · MST Antibodies, Gliadin · Immunology
Mar 2007 83d
ELIA CELIKEY IGA WELL, MODEL 14-5517-01; ELIA CELIAC CONTROL, MODEL 83-1011-01
K062787 · MVM Autoantibodies,... · Immunology
Dec 2006 102d
ELIA CELIKEY IGG WELL, MODEL 14-5518-01, ELIA CELIAC CONTROL, MODEL 83-1011-01
K062583 · MVM Autoantibodies,... · Immunology
Dec 2006 116d
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