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

    IMMUNOCAP SPECIFIC IGE ALLERGEN BUNDLE, 12 ALLERGEN COMPONENTS

    K Number: K111919 · Decision Dec 22, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    17
    Registration Numbers
    17
    Same Product Code
    265
    Applicant Total
    22
    Review Days
    168

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    Basic Information

    Device Name
    IMMUNOCAP SPECIFIC IGE ALLERGEN BUNDLE, 12 ALLERGEN COMPONENTS
    K Number
    K111919
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5750
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Phadia US, Inc.
    Date Received
    July 7, 2011
    Decision Date
    December 22, 2011
    Product Code
    DHB
    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
    DHB System, Test, Radioallergosorbent (Rast) Immunological

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