Medical Device Manufacturer · SE , Uppsala

Phadia AB

32 submissions · 32 cleared · Since 2007
32
Total
32
Cleared
0
Denied

Phadia AB — FDA 510(k) Submissions

Phadia AB has submitted 32 FDA 510(k) premarket notifications since 2007, of which 32 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include System, Test, Radioallergosorbent (rast) Immunological, Anti-sm Antibody, Antigen And Control, Ige, Antigen, Antiserum, Control, Extractable Antinuclear Antibody, Antigen And Control, Anti-ribosomal P Antibodies . Use the specialty filter in the sidebar to narrow results.

32 devices
1–25 of 32
ImmunoCAP Allergen f433, Allergen component rTri a 14 LTP, Wheat, ImmunoCAP Allergen f416, Allergen component rTri a 19 Omega-5 Gliadin, Wheat, ImmunoCAP Allergen f449, Allergen component rSes i 1 Sesame seed
K212181 · DHB System, Test,... · Immunology
Aug 2022 386d
EliA Ro52, EliA Ro60
K210902 · LKJ Antinuclear Antibody,... · Immunology
Jul 2022 488d
EliA Rib-P
K202540 · MQA Anti-ribosomal P Antibodies · Immunology
Sep 2021 376d
EliA RNA Pol III
K202541 · NYO Autoantibodies,... · Immunology
Sep 2021 376d
EliA SmDP-S
K202067 · LKP Anti-sm Antibody, Antigen... · Immunology
Jul 2021 352d
ImmunoCAP Allergen o215, Component nGal-alpha-1,3-Gal(alpha-Gal) Thyroglobulin, bovine
K200279 · DHB System, Test,... · Immunology
May 2020 87d
EliA SymphonyS Immunoassay
K190710 · LLL Extractable Antinuclear... · Immunology
Nov 2019 255d
ImmunoCAP Allergen e229, Allergen Component rCan f 4 Dog, ImmunoCAP Allergen e230, Allergen Component rCan f 6 Dog, ImmunoCAP Allergen e231, Allergen Component rFel d 7 Cat
K190315 · DHB System, Test,... · Immunology
May 2019 90d
EliA Celikey IgG Immunoassay; EliA GliadinDP IgA Immunoassay; EliA GliadinDP IgG Immunoassay
K181871 · MVM Autoantibodies,... · Immunology
Mar 2019 232d
EliA SmDP Immunoassay
K183007 · LKP Anti-sm Antibody, Antigen... · Immunology
Dec 2018 54d
EliA RF IgM Immunoassay
K182747 · DHR System, Test, Rheumatoid... · Immunology
Dec 2018 81d
EliA CENP Immunoassay, EliA U1RNP Immunoassay, EliA RNP70 Immunoassay
K182353 · LJM Antinuclear Antibody... · Immunology
Nov 2018 90d
EliA M2 Immunoassay
K181556 · DBM Antimitochondrial... · Immunology
Jul 2018 30d
EliA B2-Glycoprotein I IgA Immunoassay, EliA Cardiolipin IgA Immunoassay
K181329 · MSV System,test,antibodies,b2... · Immunology
Jun 2018 38d
ImmunoCAP Specific IgE, ImmunoCAP Allergen f447, Allergen Component rAra h 6, Peanut
K173726 · DHB System, Test,... · Immunology
Apr 2018 132d
EliA PR3s Immunoassay; EliA MPOs Immunoassay; EliA GBM Immunoassay
K173792 · MOB Test System,... · Immunology
Mar 2018 89d
ImmunoCAP Tryptase, ImmunoCAP Tryptase Calibrators, ImmunoCAP Tryptase Curve Control, ImmunoCAP Tryptase Conjugate 50, ImmunoCAP Tryptase Calibrator Strip, ImmunoCAP Tryptase Curve Control Strip
K173704 · OYL Tryptase Assay System · Immunology
Mar 2018 88d
ImmunoCAP Allergen w1, Common ragweed; ImmunoCAP Specific IgE
K163370 · DHB System, Test,... · Immunology
May 2017 155d
ImmunoCAP Total IgE Calibrator Strip/Total IgE Curve Control Strip, ImmunoCAP Total IgE Calibrators/Total IgE Curve Controls, ImmunoCAP Specific IgE Calibrator Strip/Specific IgE Curve Control Strip, ImmunoCAP Specific IgE Calibrators/Specific IgE Curve Controls
K161899 · DGC Ige, Antigen, Antiserum,... · Immunology
Jul 2016 17d
EliA anti-TG Immunoassay, EliA anti-TPO Immunoassay, EliA Thyroid Positive Control 250, EliA Thyroid Positive Control 2500/5000
K151799 · JZO System, Test, Thyroid... · Immunology
Mar 2016 267d
ImmunoCAP Allergen d202, Allergen component rDer p 1,House dust mite
K150597 · DHB System, Test,... · Immunology
Feb 2016 357d
Phadia Prime
K151029 · DHB System, Test,... · Immunology
Jan 2016 277d
ImmunoCAP Specific IgE; ImmunoCAP Allergen f439, Hazelnut; ImmunoCAP Allergen f440, Hazelnut; ImmunoCAP Allergen f441, Walnut; ImmunoCAP Allergen f442, Walnut; ImmunoCAP Allergen f443, Cashew nut
K150854 · DHB System, Test,... · Immunology
Dec 2015 258d
IMMUNOCAP TOTAL IGE: CONJUGATE, ANTI-IGE, CALIBRATORS, CURVE CONTROLS, CONTROL LMH
K133404 · DGC Ige, Antigen, Antiserum,... · Immunology
Feb 2014 110d
IMMUNOCAP SPECIFIC IGE CONTROL L, IMMUNOCAP SPECIFIC IGE CONTROL M AND IMMUNOCAP SPECIFIC IGE CONTROL H
K131738 · DHB System, Test,... · Immunology
Jul 2013 27d
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