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

    EUROGENETICS CRP ELISA

    K Number: K872539 · Decision Oct 20, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    33
    Registration Numbers
    33
    Same Product Code
    69
    Applicant Total
    1
    Review Days
    113

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    Basic Information

    Device Name
    EUROGENETICS CRP ELISA
    K Number
    K872539
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5270
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Applicant
    Eurogenetics
    Date Received
    June 29, 1987
    Decision Date
    October 20, 1987
    Product Code
    DCN
    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
    DCN System, Test, C-Reactive Protein

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