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

    DCA VANTAGE, MODEL 5075

    K Number: K071466 · Decision Oct 9, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    65
    Registration Numbers
    65
    Same Product Code
    248
    Applicant Total
    11
    Review Days
    133

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    Basic Information

    Device Name
    DCA VANTAGE, MODEL 5075
    K Number
    K071466
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    864.7470
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Siemens Medical Solutions Diagnostics
    Date Received
    May 29, 2007
    Decision Date
    October 9, 2007
    Product Code
    LCP
    Advisory Committee
    Hematology
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LCP Assay, Glycosylated Hemoglobin

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