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

    23andMe Personal Genome Service (PGS) Genetic Health Risk Test for Hereditary Thrombophilia

    K Number: DEN160026 · Decision Apr 6, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    4
    Applicant Total
    8
    Review Days
    282

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    Basic Information

    Device Name
    23andMe Personal Genome Service (PGS) Genetic Health Risk Test for Hereditary Thrombophilia
    K Number
    DEN160026
    Device Class
    FDA class 2
    Clearance Type
    Direct
    Regulation Number
    866.5950
    Medical Specialty
    Immunology
    Decision
    Unknown
    Applicant
    23AndMe, Inc.
    Date Received
    June 28, 2016
    Decision Date
    April 6, 2017
    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 23AndMe, Inc.

    K Number Device Name
    K223597 23andMe® Personal Genome Service® (PGS®) Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants)
    K221885 23andMe Personal Genome Service (PGS) Pharmacogenetic Reports
    K211499 23andMe PGS Genetic Risk Report for Hereditary Prostate Cancer (HOXB13-Related)
    K193492 23andMe Personal Genome Service (PGS) Pharmacogenetic Reports
    K182784 MUTYH-Associated Polyposis (MAP)
    DEN180028 23andMe Personal Genome Service (PGS) Pharmacogenetic Reports
    DEN170046 23andMe PGS Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants)