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

    23ANDME PERSONAL GENOME SERVICE (HEREINAFTER KNOWN AS PGS)

    K Number: DEN140044 · Decision Feb 19, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    0
    Applicant Total
    1
    Review Days
    266

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    23ANDME PERSONAL GENOME SERVICE (HEREINAFTER KNOWN AS PGS)
    K Number
    DEN140044
    Device Class
    FDA class 2
    Clearance Type
    Direct
    Regulation Number
    866.5940
    Medical Specialty
    Immunology
    Decision
    Unknown
    Applicant
    23AndMe
    Date Received
    May 29, 2014
    Decision Date
    February 19, 2015
    Product Code
    PKB
    Advisory Committee
    Immunology
    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
    PKB Autosomal Recessive Carrier Screening Gene Mutation Detection System