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

    QXDx BCR-ABL %IS Kit for use on the QXDx AutoDG ddPCR System

    K Number: K181661 · Decision Feb 13, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    4
    Applicant Total
    82
    Review Days
    233

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    Basic Information

    Device Name
    QXDx BCR-ABL %IS Kit for use on the QXDx AutoDG ddPCR System
    K Number
    K181661
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.6060
    Medical Specialty
    Medical Genetics
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Bio-Rad Laboratories, Inc.
    Date Received
    June 25, 2018
    Decision Date
    February 13, 2019
    Product Code
    OYX
    Advisory Committee
    Medical Genetics
    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
    OYX Bcr/Abl1 Monitoring Test

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