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

    AncestryDNA Saliva Collection Kit

    K Number: K192947 · Decision Aug 13, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    16
    Registration Numbers
    16
    Same Product Code
    6
    Applicant Total
    2
    Review Days
    300

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    Basic Information

    Device Name
    AncestryDNA Saliva Collection Kit
    K Number
    K192947
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1675
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ancestry Genomics, Inc.
    Date Received
    October 18, 2019
    Decision Date
    August 13, 2020
    Product Code
    OYJ
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

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

    Product Code Device Name
    OYJ Dna Specimen Collection, Saliva

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    Other Clearances by Ancestry Genomics, Inc.

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