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

    AGGLUTINATION TEST FOR TOTAL IGE

    K Number: K843369 · Decision Nov 14, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    30
    Registration Numbers
    30
    Same Product Code
    113
    Applicant Total
    5
    Review Days
    78

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    Basic Information

    Device Name
    AGGLUTINATION TEST FOR TOTAL IGE
    K Number
    K843369
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5510
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Applicant
    Scientific Research
    Date Received
    August 28, 1984
    Decision Date
    November 14, 1984
    Product Code
    DGC
    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
    DGC Ige, Antigen, Antiserum, Control

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