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

    Invitae Common Hereditary Cancers Panel

    K Number: DEN210011 · Decision Sep 29, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    0
    Applicant Total
    1
    Review Days
    914

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    Basic Information

    Device Name
    Invitae Common Hereditary Cancers Panel
    K Number
    DEN210011
    Device Class
    FDA class 2
    Clearance Type
    Direct
    Regulation Number
    866.6095
    Medical Specialty
    Pathology
    Decision
    Unknown
    Applicant
    Invitae Corporation
    Date Received
    March 29, 2021
    Decision Date
    September 29, 2023
    Product Code
    QVU
    Advisory Committee
    Pathology
    Review Advisory Committee
    MG
    Third Party
    N

    Classifications

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

    Product Code Device Name
    QVU High Throughput Dna Sequencing For Hereditary Cancer Predisposition Assessment Test System.