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

    IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT

    K Number: K093107 · Decision Sep 30, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    17
    Registration Numbers
    17
    Same Product Code
    265
    Applicant Total
    92
    Review Days
    364

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    Basic Information

    Device Name
    IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT
    K Number
    K093107
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5750
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Siemens Healthcare Diagnostics
    Date Received
    October 1, 2009
    Decision Date
    September 30, 2010
    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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