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

    QUIDEL TOTAL IGE TEST QUANTITATIVE VERSION

    K Number: K894039 · Decision Jul 14, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    14
    Applicant Total
    93
    Review Days
    38

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    Basic Information

    Device Name
    QUIDEL TOTAL IGE TEST QUANTITATIVE VERSION
    K Number
    K894039
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5510
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Applicant
    Quidel Corp.
    Date Received
    June 6, 1989
    Decision Date
    July 14, 1989
    Product Code
    DGO
    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
    DGO Ige, Peroxidase, Antigen, Antiserum, Control

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