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

    ANTI-THYROGLOBULIN TEST KIT

    K Number: K894203 · Decision Jul 25, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    35
    Registration Numbers
    35
    Same Product Code
    91
    Applicant Total
    4
    Review Days
    36

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    Basic Information

    Device Name
    ANTI-THYROGLOBULIN TEST KIT
    K Number
    K894203
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5870
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Applicant
    Kronus
    Date Received
    June 19, 1989
    Decision Date
    July 25, 1989
    Product Code
    JZO
    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
    JZO System, Test, Thyroid Autoantibody

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    Other Clearances by Kronus

    K Number Device Name
    K915429 KRONUS KALIBRE THYROID PEROXIDASE ANTIBODY EIA KIT
    K915428 KRONUS KALIBRE THYROGLOBULIN ANTIBODY EIA KIT
    K894364 MODIFIED KRONUS TEST KIT FOR ANTIBODIES TO (TPO)