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

    PHICAL TEST

    K Number: DEN060001 · Decision Apr 26, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    14
    Applicant Total
    1
    Review Days
    34

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    Basic Information

    Device Name
    PHICAL TEST
    K Number
    DEN060001
    Device Class
    FDA class 2
    Clearance Type
    Post-NSE
    Regulation Number
    866.5180
    Medical Specialty
    Immunology
    Decision
    Unknown
    Applicant
    Genova Diagnostics
    Date Received
    March 23, 2006
    Decision Date
    April 26, 2006
    Product Code
    NXO
    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
    NXO Calprotectin, Fecal

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