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

    ALASTAT ALLERGEN SPECIFIED IGE SYSTEM, MODIFIED

    K Number: K911511 · Decision Apr 17, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    14
    Applicant Total
    321
    Review Days
    13

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    Basic Information

    Device Name
    ALASTAT ALLERGEN SPECIFIED IGE SYSTEM, MODIFIED
    K Number
    K911511
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5510
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Applicant
    Diagnostic Products Corp.
    Date Received
    April 4, 1991
    Decision Date
    April 17, 1991
    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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