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

    EliA SmDP-S

    K Number: K202067 · Decision Jul 14, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    17
    Registration Numbers
    17
    Same Product Code
    27
    Applicant Total
    32
    Review Days
    352

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    Basic Information

    Device Name
    EliA SmDP-S
    K Number
    K202067
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5100
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Phadia AB
    Date Received
    July 27, 2020
    Decision Date
    July 14, 2021
    Product Code
    LKP
    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
    LKP Anti-Sm Antibody, Antigen And Control

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    Other Clearances by Phadia AB

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    K200279 ImmunoCAP Allergen o215, Component nGal-alpha-1,3-Gal(alpha-Gal) Thyroglobulin, bovine
    K190710 EliA SymphonyS Immunoassay
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    K181871 EliA Celikey IgG Immunoassay; EliA GliadinDP IgA Immunoassay; EliA GliadinDP IgG Immunoassay
    K183007 EliA SmDP Immunoassay
    K182747 EliA RF IgM Immunoassay
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