FDA 510(k) Applications Submitted by PHADIA AB

FDA 510(k) Number Submission Date Device Name Applicant
K151029 04/17/2015 Phadia Prime PHADIA AB
K150597 03/09/2015 ImmunoCAP Allergen d202, Allergen component rDer p 1,House dust mite PHADIA AB
K150854 03/31/2015 ImmunoCAP Specific IgE; ImmunoCAP Allergen f439, Hazelnut; ImmunoCAP Allergen f440, Hazelnut; ImmunoCAP Allergen f441, Walnut; ImmunoCAP Allergen f442, Walnut; ImmunoCAP Allergen f443, Cashew nut PHADIA AB
K181329 05/18/2018 EliA B2-Glycoprotein I IgA Immunoassay, EliA Cardiolipin IgA Immunoassay Phadia AB
K131738 06/13/2013 IMMUNOCAP SPECIFIC IGE CONTROL L, IMMUNOCAP SPECIFIC IGE CONTROL M AND IMMUNOCAP SPECIFIC IGE CONTROL H PHADIA AB
K181556 06/13/2018 EliA M2 Immunoassay Phadia AB
K151799 07/02/2015 EliA anti-TG Immunoassay, EliA anti-TPO Immunoassay, EliA Thyroid Positive Control 250, EliA Thyroid Positive Control 2500/5000 PHADIA AB
K163370 12/01/2016 ImmunoCAP Allergen w1, Common ragweed; ImmunoCAP Specific IgE PHADIA AB
K173704 12/04/2017 ImmunoCAP Tryptase, ImmunoCAP Tryptase Calibrators, ImmunoCAP Tryptase Curve Control, ImmunoCAP Tryptase Conjugate 50, ImmunoCAP Tryptase Calibrator Strip, ImmunoCAP Tryptase Curve Control Strip Phadia AB
K173792 12/14/2017 EliA PR3s Immunoassay; EliA MPOs Immunoassay; EliA GBM Immunoassay Phadia AB
K071913 07/11/2007 IMMUNOCAP ALLERGEN F338, SCALLOP WITH MODEL(S): 14-4895-01 PHADIA AB
K100999 04/12/2010 IMMUNOCAP ALLERGEN F20, ALMOND MODEL: 14-4179-01 PHADIA AB
K121156 04/16/2012 AUTOMATED IN VITRO QUANTITATIVE ASSAY FOR THE MEASUREMENT OF ALLERGEN SPECIFIC IGE ANTIBODIES PHADIA AB
K101251 05/04/2010 IMMUNOCAP ALLERGEN D202, ALLERGEN COMPONENT NDER P 1, HOUSE DUST MITE, IMMUNOCAP ALLERGEN D203, ALLERGEN PHADIA AB
K081830 06/30/2008 IMMUNOCAP RAPID INHALANT PROFILE , IMMUNOCAP RAPID READER, IMMUNOCAP RAPID READER CHECK DEVICE, AND IMMUNOCAP RAPID QC1 PHADIA AB
K092050 07/07/2009 IMMUNOCAP ALLERGEN D201, HOUSE DUST MITE, MODEL 4-4896-01 PHADIA AB
K123275 10/19/2012 IMMUNOCAP ALLERGEN i3, COMMON WASP VENOM (YELLOW JACKET), AND IMMUNOCAP ALLERGEN i4, PAPER WASP VENOM PHADIA AB
K133404 11/06/2013 IMMUNOCAP TOTAL IGE: CONJUGATE, ANTI-IGE, CALIBRATORS, CURVE CONTROLS, CONTROL LMH PHADIA AB
K161899 07/11/2016 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 C PHADIA AB
K173726 12/05/2017 ImmunoCAP Specific IgE, ImmunoCAP Allergen f447, Allergen Component rAra h 6, Peanut Phadia AB


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