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

    23andMe PGS Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants)

    K Number: DEN170046 · Decision Mar 6, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    3
    Applicant Total
    8
    Review Days
    182

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    Basic Information

    Device Name
    23andMe PGS Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants)
    K Number
    DEN170046
    Device Class
    FDA class 2
    Clearance Type
    Direct
    Regulation Number
    866.6090
    Medical Specialty
    Medical Genetics
    Decision
    Unknown
    Applicant
    23AndMe, Inc.
    Date Received
    September 5, 2017
    Decision Date
    March 6, 2018
    Product Code
    QAZ
    Advisory Committee
    Medical Genetics
    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
    QAZ Cancer Predisposition Risk Assessment System

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (QAZ), ordered by most recent decision date.

    23andMe® Personal Genome Service® (PGS®) Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants)

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    23andMe PGS Genetic Risk Report for Hereditary Prostate Cancer (HOXB13-Related)

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    FDA Class 2 ·Medical Genetics

    MUTYH-Associated Polyposis (MAP)

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    View all

    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
    DEN160026 23andMe Personal Genome Service (PGS) Genetic Health Risk Test for Hereditary Thrombophilia