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

    ADVIA Centaur Vitamin D Total (VitD)

    K Number: K200509 · Decision May 29, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    51
    Registration Numbers
    51
    Same Product Code
    45
    Applicant Total
    152
    Review Days
    88

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    Basic Information

    Device Name
    ADVIA Centaur Vitamin D Total (VitD)
    K Number
    K200509
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1825
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Siemens Healthcare Diagnostics, Inc.
    Date Received
    March 2, 2020
    Decision Date
    May 29, 2020
    Product Code
    MRG
    Advisory Committee
    Clinical Chemistry
    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
    MRG System, Test, Vitamin D

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