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

    MRDx BCR-ABL Test, MRDx BCR-ABL Test Software

    K Number: K173492 · Decision Dec 22, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    4
    Applicant Total
    1
    Review Days
    39

    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
    MRDx BCR-ABL Test, MRDx BCR-ABL Test Software
    K Number
    K173492
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.6060
    Medical Specialty
    Medical Genetics
    Decision
    Unknown
    Statement or Summary
    Summary
    Applicant
    Molecularmd Corporation
    Date Received
    November 13, 2017
    Decision Date
    December 22, 2017
    Product Code
    OYX
    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
    OYX Bcr/Abl1 Monitoring Test

    Similar 510(k) Clearances

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

    BCR-ABL1 (p210) % IS Kit (Digital PCR Method)

    FDA 510(k)
    FDA Class 2 ·Medical Genetics

    Xpert BCR-ABL Ultra, GeneXpert Dx System, GeneXpert Infinity-48s and GeneXpert Infinity-80 Systems

    FDA 510(k)
    FDA Class 2 ·Medical Genetics

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

    FDA 510(k)
    FDA Class 2 ·Medical Genetics

    Quantidex qPCR BCR-ABL IS Kit

    FDA 510(k)
    FDA Class 2 ·Medical Genetics
    View all