BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇸🇪 Sweden

    EliA PR3s Immunoassay; EliA MPOs Immunoassay; EliA GBM Immunoassay

    K Number: K173792 · Decision Mar 13, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    26
    Registration Numbers
    26
    Same Product Code
    73
    Applicant Total
    32
    Review Days
    89

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    Basic Information

    Device Name
    EliA PR3s Immunoassay; EliA MPOs Immunoassay; EliA GBM Immunoassay
    K Number
    K173792
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5660
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Phadia AB
    Date Received
    December 14, 2017
    Decision Date
    March 13, 2018
    Product Code
    MOB
    Advisory Committee
    Immunology
    Review Advisory Committee
    IM
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MOB Test System, Antineutrophil Cytoplasmic Antibodies (Anca)

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    Other Clearances by Phadia AB

    K Number Device Name
    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 seed
    K210902 EliA Ro52, EliA Ro60
    K202540 EliA Rib-P
    K202541 EliA RNA Pol III
    K202067 EliA SmDP-S
    K200279 ImmunoCAP Allergen o215, Component nGal-alpha-1,3-Gal(alpha-Gal) Thyroglobulin, bovine
    K190710 EliA SymphonyS Immunoassay
    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 Cat
    K181871 EliA Celikey IgG Immunoassay; EliA GliadinDP IgA Immunoassay; EliA GliadinDP IgG Immunoassay
    K183007 EliA SmDP Immunoassay
    Search all 32 clearances from Phadia AB →