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

    ANTI-LEU-12 B CELL REAGENT

    K Number: K851639 · Decision Jul 2, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    0
    Applicant Total
    632
    Review Days
    439

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    Basic Information

    Device Name
    ANTI-LEU-12 B CELL REAGENT
    K Number
    K851639
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.5220
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Bd Becton Dickinson Vacutainer Systems Preanalytic
    Date Received
    April 19, 1985
    Decision Date
    July 2, 1986
    Product Code
    LJD
    Advisory Committee
    Hematology
    Review Advisory Committee
    HE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    LJD Assay, B Lymphocyte Marker

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