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Phadia AB

33 FDA 510(k) clearances · Manufacturer

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RecordFirmDate
EliA CTD 13 Screen (K253367)Phadia AB2026-06-25
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)Phadia AB2022-08-03
EliA Ro52, EliA Ro60 (K210902)Phadia AB2022-07-27
EliA Rib-P (K202540)Phadia AB2021-09-13
EliA RNA Pol III (K202541)Phadia AB2021-09-13
EliA SmDP-S (K202067)Phadia AB2021-07-14
ImmunoCAP Allergen o215, Component nGal-alpha-1,3-Gal(alpha-Gal) Thyroglobulin, bovine (K200279)Phadia AB2020-05-01
EliA SymphonyS Immunoassay (K190710)Phadia AB2019-11-29
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)Phadia AB2019-05-14
EliA Celikey IgG Immunoassay; EliA GliadinDP IgA Immunoassay; EliA GliadinDP IgG Immunoassay (K181871)Phadia AB2019-03-01
EliA SmDP Immunoassay (K183007)Phadia AB2018-12-24
EliA RF IgM Immunoassay (K182747)Phadia AB2018-12-18
EliA CENP Immunoassay, EliA U1RNP Immunoassay, EliA RNP70 Immunoassay (K182353)Phadia AB2018-11-27
EliA M2 Immunoassay (K181556)Phadia AB2018-07-13
EliA B2-Glycoprotein I IgA Immunoassay, EliA Cardiolipin IgA Immunoassay (K181329)Phadia AB2018-06-25
ImmunoCAP Specific IgE, ImmunoCAP Allergen f447, Allergen Component rAra h 6, Peanut (K173726)Phadia AB2018-04-16
EliA PR3s Immunoassay; EliA MPOs Immunoassay; EliA GBM Immunoassay (K173792)Phadia AB2018-03-13
ImmunoCAP Tryptase, ImmunoCAP Tryptase Calibrators, ImmunoCAP Tryptase Curve Control, ImmunoCAP Tryptase Conjugate 50, ImmunoCAP Tryptase Calibrator Strip, ImmunoCAP Tryptase Curve Control Strip (K173704)Phadia AB2018-03-02
ImmunoCAP Allergen w1, Common ragweed; ImmunoCAP Specific IgE (K163370)Phadia AB2017-05-05
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)Phadia AB2016-07-28
EliA anti-TG Immunoassay, EliA anti-TPO Immunoassay, EliA Thyroid Positive Control 250, EliA Thyroid Positive Control 2500/5000 (K151799)Phadia AB2016-03-25
ImmunoCAP Allergen d202, Allergen component rDer p 1,House dust mite (K150597)Phadia AB2016-02-29
Phadia Prime (K151029)Phadia AB2016-01-19
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)Phadia AB2015-12-14
IMMUNOCAP TOTAL IGE: CONJUGATE, ANTI-IGE, CALIBRATORS, CURVE CONTROLS, CONTROL LMH (K133404)Phadia AB2014-02-24
IMMUNOCAP SPECIFIC IGE CONTROL L, IMMUNOCAP SPECIFIC IGE CONTROL M AND IMMUNOCAP SPECIFIC IGE CONTROL H (K131738)Phadia AB2013-07-10
IMMUNOCAP ALLERGEN i3, COMMON WASP VENOM (YELLOW JACKET), AND IMMUNOCAP ALLERGEN i4, PAPER WASP VENOM (K123275)Phadia AB2013-06-28
AUTOMATED IN VITRO QUANTITATIVE ASSAY FOR THE MEASUREMENT OF ALLERGEN SPECIFIC IGE ANTIBODIES (K121156)Phadia AB2013-03-13
IMMUNOCAP ALLERGEN D202, ALLERGEN COMPONENT NDER P 1, HOUSE DUST MITE, IMMUNOCAP ALLERGEN D203, ALLERGEN (K101251)Phadia AB2011-05-27
IMMUNOCAP ALLERGEN F20, ALMOND MODEL: 14-4179-01 (K100999)Phadia AB2010-12-15
IMMUNOCAP ALLERGEN D201, HOUSE DUST MITE, MODEL 4-4896-01 (K092050)Phadia AB2009-11-20
IMMUNOCAP RAPID INHALANT PROFILE , IMMUNOCAP RAPID READER, IMMUNOCAP RAPID READER CHECK DEVICE, AND IMMUNOCAP RAPID QC1 (K081830)Phadia AB2009-03-16
IMMUNOCAP ALLERGEN F338, SCALLOP WITH MODEL(S): 14-4895-01 (K071913)Phadia AB2007-08-24

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Every clearance here is in the API, with alerts when new ones post.