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

    FIAX TOXO-M ANTIBODIES TEST KIT

    K Number: K850591 · Decision Apr 30, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    17
    Applicant Total
    29
    Review Days
    75

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    Basic Information

    Device Name
    FIAX TOXO-M ANTIBODIES TEST KIT
    K Number
    K850591
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3780
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Intl. Diagnostic Technology
    Date Received
    February 14, 1985
    Decision Date
    April 30, 1985
    Product Code
    GLZ
    Advisory Committee
    Microbiology
    Review Advisory Committee
    MI
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    GLZ Antigens, If, Toxoplasma Gondii

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