BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇪 Germany

    CardioPhase® hsCRP

    K Number: K212559 · Decision Dec 16, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24
    Same Product Code
    18
    Applicant Total
    19
    Review Days
    490

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    Basic Information

    Device Name
    CardioPhase® hsCRP
    K Number
    K212559
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    866.5270
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Siemens Healthcare Diagnostics Products GmbH
    Date Received
    August 13, 2021
    Decision Date
    December 16, 2022
    Product Code
    NQD
    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
    NQD Cardiac C-Reactive Protein, Antigen, Antiserum, And Control

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