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

    Omics Core

    K Number: K190661 · Decision Nov 9, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    7
    Applicant Total
    1
    Review Days
    240

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    Basic Information

    Device Name
    Omics Core
    K Number
    K190661
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.6080
    Medical Specialty
    Pathology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Nanthealth, Inc.
    Date Received
    March 14, 2019
    Decision Date
    November 9, 2019
    Product Code
    PZM
    Advisory Committee
    Pathology
    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
    PZM Next Generation Sequencing Based Tumor Profiling Test

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