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

    AncestryDNA Factor V Leiden Genetic Health Risk Test

    K Number: K192944 · Decision Aug 13, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    4
    Applicant Total
    2
    Review Days
    300

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    Basic Information

    Device Name
    AncestryDNA Factor V Leiden Genetic Health Risk Test
    K Number
    K192944
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5950
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ancestry Genomics, Inc.
    Date Received
    October 18, 2019
    Decision Date
    August 13, 2020
    Product Code
    PTA
    Advisory Committee
    Immunology
    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
    PTA Genetic Variant Detection And Health Risk Assessment System

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    Other Clearances by Ancestry Genomics, Inc.

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