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

    RCRP Flex reagent cartridge

    K Number: K221119 · Decision Mar 17, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    33
    Registration Numbers
    33
    Same Product Code
    69
    Applicant Total
    152
    Review Days
    333

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    Basic Information

    Device Name
    RCRP Flex reagent cartridge
    K Number
    K221119
    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, Inc.
    Date Received
    April 18, 2022
    Decision Date
    March 17, 2023
    Product Code
    DCN
    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
    DCN System, Test, C-Reactive Protein

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