BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit

    K Number: K171731 · Decision Jan 19, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    2
    Applicant Total
    5
    Review Days
    221

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    Basic Information

    Device Name
    KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit
    K Number
    K171731
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5660
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Kronus, Inc.
    Date Received
    June 12, 2017
    Decision Date
    January 19, 2018
    Product Code
    OIF
    Advisory Committee
    Immunology
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

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

    Product Code Device Name
    OIF Tyrosine Phosphatase (Ia-2) Autoantibody Assay

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    Other Clearances by Kronus, Inc.

    K Number Device Name
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    K161951 KRONUS Aquaporin-4 Autoantibody (AQP4Ab) ELISA Assay
    DEN150030 KRONUS Aquaporin-4 Autoantibody (AQP4Ab) ELISA Assay