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

    Xpert® FII & FV

    K Number: K250218 · Decision Feb 21, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    4
    Applicant Total
    50
    Review Days
    28

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    Basic Information

    Device Name
    Xpert® FII & FV
    K Number
    K250218
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    864.7280
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cepheid
    Date Received
    January 24, 2025
    Decision Date
    February 21, 2025
    Product Code
    NPR
    Advisory Committee
    Hematology
    Review Advisory Committee
    HE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    NPR Test, Factor Ii G20210a Mutations, Genomic Dna Pcr

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