BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Dna-Probe, B And T Lymphocyte

    PMA: P880016 · Supplement: S004 · Decision Jan 13, 1993
    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
    Supplement Number
    S004
    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
    January 13, 1993
    Date Received
    August 26, 1992
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    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