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

    ADVIA Centaur CA 15-3 assay

    K Number: K192777 · Decision Nov 22, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    25
    Registration Numbers
    25
    Same Product Code
    27
    Applicant Total
    152
    Review Days
    53

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    Basic Information

    Device Name
    ADVIA Centaur CA 15-3 assay
    K Number
    K192777
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.6010
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Siemens Healthcare Diagnostics, Inc.
    Date Received
    September 30, 2019
    Decision Date
    November 22, 2019
    Product Code
    MOI
    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
    MOI System, Test, Immunological, Antigen, Tumor

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