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

    ADVIA CHEMISTRY LIPOPROTEIN(A) REAGENT ADVIA CHEMISTRY LIPOPROTEIN(A) CALIBRATOR

    K Number: K123046 · Decision Dec 20, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28
    Same Product Code
    41
    Applicant Total
    88
    Review Days
    83

    Basic Information

    Device Name
    ADVIA CHEMISTRY LIPOPROTEIN(A) REAGENT ADVIA CHEMISTRY LIPOPROTEIN(A) CALIBRATOR
    K Number
    K123046
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5600
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Siemens Healthcare Diagnostics Inc.
    Date Received
    September 28, 2012
    Decision Date
    December 20, 2012
    Product Code
    DFC
    Advisory Committee
    Immunology
    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
    DFC Lipoprotein, Low-Density, Antigen, Antiserum, Control

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