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

    FIAX TEST KIT FOR ANTI-CYTOMEGALORIRUS

    K Number: K791948 · Decision Nov 16, 1979
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    18
    Applicant Total
    29
    Review Days
    46

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    Basic Information

    Device Name
    FIAX TEST KIT FOR ANTI-CYTOMEGALORIRUS
    K Number
    K791948
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3175
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Intl. Diagnostic Technology
    Date Received
    October 1, 1979
    Decision Date
    November 16, 1979
    Product Code
    GQH
    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
    GQH Antigen, Cf (Including Cf Control), Cytomegalovirus

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    Other Clearances by Intl. Diagnostic Technology

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    K843356 FIAX 100 FLUOROMETER
    K842749 FIAX TOTAL IGE TEST KIT
    K842071 FIAX TRANSFERRIN TEST KIT
    K841174 RUBELLA ANTIBODY FLUOROIMMUNOASSAY
    K840867 ALPHA-1-ANTITRYPSIN, FITC, ANTIGEN
    K834140 ANTINUCLEAR ANTIBODY IMMUNOLOGICAL SYS
    K833984 ANTINUCLEAR ANTIBODY IMMUNOLOGICAL
    Search all 29 clearances from Intl. Diagnostic Technology →