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Phadia AB

FDA 510(k) & PMA Approved Devices — 23 products

Total Devices23
Categories15
Latest FDA decision2026-06-25
TypeNumberDevice NameCodeDateActions
510(k) K253367 EliA CTD 13 ScreenLLL2026-06-25 View
510(k) K212181 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 seedDHB2022-08-03 View
510(k) K210902 EliA Ro52, EliA Ro60LKJ2022-07-27 View
510(k) K202541 EliA RNA Pol IIINYO2021-09-13 View
510(k) K202540 EliA Rib-PMQA2021-09-13 View
510(k) K202067 EliA SmDP-SLKP2021-07-14 View
510(k) K200279 ImmunoCAP Allergen o215, Component nGal-alpha-1,3-Gal(alpha-Gal) Thyroglobulin, bovineDHB2020-05-01 View
510(k) K190710 EliA SymphonyS ImmunoassayLLL2019-11-29 View
510(k) K190315 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 CatDHB2019-05-14 View
510(k) K181871 EliA Celikey IgG Immunoassay; EliA GliadinDP IgA Immunoassay; EliA GliadinDP IgG ImmunoassayMVM2019-03-01 View
510(k) K183007 EliA SmDP ImmunoassayLKP2018-12-24 View
510(k) K182747 EliA RF IgM ImmunoassayDHR2018-12-18 View
510(k) K182353 EliA CENP Immunoassay, EliA U1RNP Immunoassay, EliA RNP70 ImmunoassayLJM2018-11-27 View
510(k) K181556 EliA M2 ImmunoassayDBM2018-07-13 View
510(k) K181329 EliA B2-Glycoprotein I IgA Immunoassay, EliA Cardiolipin IgA ImmunoassayMSV2018-06-25 View
510(k) K173726 ImmunoCAP Specific IgE, ImmunoCAP Allergen f447, Allergen Component rAra h 6, PeanutDHB2018-04-16 View
510(k) K173792 EliA PR3s Immunoassay; EliA MPOs Immunoassay; EliA GBM ImmunoassayMOB2018-03-13 View
510(k) K173704 ImmunoCAP Tryptase, ImmunoCAP Tryptase Calibrators, ImmunoCAP Tryptase Curve Control, ImmunoCAP Tryptase Conjugate 50, ImmunoCAP Tryptase Calibrator Strip, ImmunoCAP Tryptase Curve Control StripOYL2018-03-02 View
510(k) K163370 ImmunoCAP Allergen w1, Common ragweed; ImmunoCAP Specific IgEDHB2017-05-05 View
510(k) K161899 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 ControlsDGC2016-07-28 View

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