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

    XPERT HEMOSIL FACTOR II & FACTOR V ASSAY

    K Number: K082118 · Decision Sep 18, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    5
    Applicant Total
    50
    Review Days
    417

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    Basic Information

    Device Name
    XPERT HEMOSIL FACTOR II & FACTOR V ASSAY
    K Number
    K082118
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.7280
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cepheid
    Date Received
    July 28, 2008
    Decision Date
    September 18, 2009
    Product Code
    NPQ
    Advisory Committee
    Hematology
    Review Advisory Committee
    PA
    Third Party
    N

    Classifications

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

    Product Code Device Name
    NPQ Test, Factor V Leiden Mutations, Genomic Dna Pcr

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