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

    KRONUS Aquaporin-4 Autoantibody (AQP4Ab) ELISA Assay

    K Number: K161951 · Decision Jul 22, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    1
    Applicant Total
    5
    Review Days
    7

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    KRONUS Aquaporin-4 Autoantibody (AQP4Ab) ELISA Assay
    K Number
    K161951
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    866.5665
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Kronus, Inc.
    Date Received
    July 15, 2016
    Decision Date
    July 22, 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
    View all

    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
    DEN150030 KRONUS Aquaporin-4 Autoantibody (AQP4Ab) ELISA Assay