BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    THYROGLOBULIN AUTO-ANTIBODY EIA TEST KIT

    K Number: K925194 · Decision Feb 5, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    35
    Registration Numbers
    35
    Same Product Code
    91
    Applicant Total
    2
    Review Days
    113

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    Basic Information

    Device Name
    THYROGLOBULIN AUTO-ANTIBODY EIA TEST KIT
    K Number
    K925194
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5870
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Joldon Diagnostics
    Date Received
    October 15, 1992
    Decision Date
    February 5, 1993
    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 Joldon Diagnostics

    K Number Device Name
    K930274 THYROID MICROSOMAL ANTIGEN AUTO-ANTIBODY ENZYME