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

    KRONUS Aquaporin-4 Autoantibody (AQP4Ab) ELISA Assay

    K Number: DEN150030 · Decision Apr 25, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    1
    Applicant Total
    5
    Review Days
    298

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    Basic Information

    Device Name
    KRONUS Aquaporin-4 Autoantibody (AQP4Ab) ELISA Assay
    K Number
    DEN150030
    Device Class
    FDA class 2
    Clearance Type
    Direct
    Regulation Number
    866.5665
    Medical Specialty
    Immunology
    Decision
    Unknown
    Applicant
    Kronus, Inc.
    Date Received
    July 2, 2015
    Decision Date
    April 25, 2016
    Product Code
    PNI
    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
    PNI Aquaporin-4 Autoantibody

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (PNI), ordered by most recent decision date.

    KRONUS Aquaporin-4 Autoantibody (AQP4Ab) ELISA Assay

    FDA 510(k)
    FDA Class 2 ·Immunology
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    Other Clearances by Kronus, Inc.

    K Number Device Name
    K220085 KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit
    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