BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    HUMAN (IGG) SUBCLASS (EIA) KIT

    K Number: K895600 · Decision Nov 8, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    7
    Applicant Total
    113
    Review Days
    51

    Basic Information

    Device Name
    HUMAN (IGG) SUBCLASS (EIA) KIT
    K Number
    K895600
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.5530
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Applicant
    THE BINDING SITE, LTD.
    Date Received
    September 18, 1989
    Decision Date
    November 8, 1989
    Product Code
    DAS
    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
    DAS Igg (Fc Fragment Specific), Antigen, Antiserum, Control

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