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

    FIAX C4 ASSAY

    K Number: K772114 · Decision Nov 30, 1977
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    27
    Applicant Total
    5
    Review Days
    23

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    Basic Information

    Device Name
    FIAX C4 ASSAY
    K Number
    K772114
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5240
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Applicant
    Idt, A Division of Whittaker M.A. Bioproducts
    Date Received
    November 7, 1977
    Decision Date
    November 30, 1977
    Product Code
    DAK
    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
    DAK Complement C1q, Antigen, Antiserum, Control

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    Other Clearances by Idt, A Division of Whittaker M.A. Bioproducts

    K Number Device Name
    K853540 FIAX TEST KIT FOR VARICELLA ANTIBODY SEROLOGY
    K853067 FIAX TEST KIT FOR MEASLES-G ANTIBODIES FLYORESCENT
    K782041 FIAX TEST KIT
    K772219 FIAX TEST FOR ANTI-RUBELLA ANTIBODY