BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Dna-Probe, B And T Lymphocyte

    PMA: P880016 · Decision Oct 10, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Dna-Probe, B And T Lymphocyte
    Trade Name
    ONCOR B/T GENE REARRANGEMENT TEST
    PMA Number
    P880016
    Device Class
    FDA Class 2
    Product Code
    MAM
    Generic Name
    DNA-probe, b and t lymphocyte
    Regulation Number
    864.5220
    Medical Specialty
    Hematology
    Advisory Committee
    Hematology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    October 10, 1989
    Date Received
    March 1, 1988
    Expedited Review
    N
    Docket Number
    89M-0456

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MAM Dna-Probe, B And T Lymphocyte