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

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

    K Number: K220085 · Decision Aug 24, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    2
    Applicant Total
    5
    Review Days
    590

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    Basic Information

    Device Name
    KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit
    K Number
    K220085
    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
    January 11, 2022
    Decision Date
    August 24, 2023
    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
    K180607 Steroid 21-Hydroxylase Antibody (21-OHAb) ELISA Kit
    K171731 KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit
    K161951 KRONUS Aquaporin-4 Autoantibody (AQP4Ab) ELISA Assay
    DEN150030 KRONUS Aquaporin-4 Autoantibody (AQP4Ab) ELISA Assay