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

    FIAX IGM TEST KIT

    K Number: K831608 · Decision Jun 22, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    32
    Applicant Total
    29
    Review Days
    35

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    Basic Information

    Device Name
    FIAX IGM TEST KIT
    K Number
    K831608
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5550
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Applicant
    Intl. Diagnostic Technology
    Date Received
    May 18, 1983
    Decision Date
    June 22, 1983
    Product Code
    DFT
    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
    DFT Igm, Antigen, Antiserum, Control

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    Other Clearances by Intl. Diagnostic Technology

    K Number Device Name
    K850591 FIAX TOXO-M ANTIBODIES TEST KIT
    K843570 FIAX HAPTOGLOBIN TEST KIT
    K843621 FIAX 420 DILUTOR
    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 →