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

    GenetiSure Dx Postnatal Assay

    K Number: K163367 · Decision Aug 11, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    1
    Applicant Total
    30
    Review Days
    254

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    Basic Information

    Device Name
    GenetiSure Dx Postnatal Assay
    K Number
    K163367
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5920
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Agilent Technologies, Inc.
    Date Received
    November 30, 2016
    Decision Date
    August 11, 2017
    Product Code
    PFX
    Advisory Committee
    Immunology
    Review Advisory Committee
    MG
    Third Party
    N

    Classifications

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

    Product Code Device Name
    PFX System, Microarray-Based, Genome-Wide, Postnatal Chromosomal Abnormality Detection

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