BEUDAMED
    FDA 510(k) FDA class 2 Unknown 🇨🇦 Canada

    Helix Laboratory Platform

    K Number: DEN190035 · Decision Dec 23, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    0
    Applicant Total
    2
    Review Days
    509

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    Basic Information

    Device Name
    Helix Laboratory Platform
    K Number
    DEN190035
    Device Class
    FDA class 2
    Clearance Type
    Direct
    Regulation Number
    866.6000
    Medical Specialty
    Medical Genetics
    Decision
    Unknown
    Applicant
    Helix Opco, LLC
    Date Received
    August 2, 2019
    Decision Date
    December 23, 2020
    Product Code
    QNC
    Advisory Committee
    Medical Genetics
    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
    QNC Whole Exome Sequencing Constituent Device

    Other Clearances by Helix Opco, LLC

    K Number Device Name
    K192073 Helix Genetic Health Risk App for late-onset Alzheimer’s disease