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

    FIAX TOTAL IGE TEST KIT

    K Number: K842749 · Decision Aug 28, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    3
    Applicant Total
    29
    Review Days
    46

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    Basic Information

    Device Name
    FIAX TOTAL IGE TEST KIT
    K Number
    K842749
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5510
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Applicant
    Intl. Diagnostic Technology
    Date Received
    July 13, 1984
    Decision Date
    August 28, 1984
    Product Code
    DGP
    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
    DGP Ige, Fitc, Antigen, Antiserum, Control

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    ALLERGENETICS ALLER-SPECIFIC IGE SERUM

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    Other Clearances by Intl. Diagnostic Technology

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    K843356 FIAX 100 FLUOROMETER
    K842071 FIAX TRANSFERRIN TEST KIT
    K841174 RUBELLA ANTIBODY FLUOROIMMUNOASSAY
    K840867 ALPHA-1-ANTITRYPSIN, FITC, ANTIGEN
    K834140 ANTINUCLEAR ANTIBODY IMMUNOLOGICAL SYS
    K833984 ANTINUCLEAR ANTIBODY IMMUNOLOGICAL
    K832821 FIAX IGG TEST
    Search all 29 clearances from Intl. Diagnostic Technology →