BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    BUFFALO GREEN MONKEY KIDNEY CELLS-B.G.M.K.

    K Number: K934242 · Decision Jan 3, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    169
    Applicant Total
    19
    Review Days
    130

    Basic Information

    Device Name
    BUFFALO GREEN MONKEY KIDNEY CELLS-B.G.M.K.
    K Number
    K934242
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    864.2280
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    ADVANCED CLINICAL DIAGNOSTICS
    Date Received
    August 26, 1993
    Decision Date
    January 3, 1994
    Product Code
    KIR
    Advisory Committee
    Hematology
    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
    KIR Cells, Animal And Human, Cultured

    Similar 510(k) Clearances

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

    FRESH CELLS HFF

    FDA 510(k)
    FDA Class 1 ·Hematology

    FRESH CELLS VERO

    FDA 510(k)
    FDA Class 1 ·Hematology

    FRESH CELLS WI-38

    FDA 510(k)
    FDA Class 1 ·Hematology

    FRESH CELLS NCI H292

    FDA 510(k)
    FDA Class 1 ·Hematology

    FRESH CELLS MV1LU

    FDA 510(k)
    FDA Class 1 ·Hematology

    FRESH CELLS LLC-MK2

    FDA 510(k)
    FDA Class 1 ·Hematology
    View all

    Other Clearances by ADVANCED CLINICAL DIAGNOSTICS

    K Number Device Name
    K936169 RHESUS MONKEY KIDNEY CELLS
    K936171 TRANSFORMED PRIMARY HUMAN EMBRYONAL KIDNEY
    K936172 RHESUS MONKEY KIDNEY CELLS (LLC-MK2)
    K934934 RABBIT KIDNEY CELLS - R.K.C.
    K934973 HELA-229/HELA CELLS
    K935766 PRIMARY AFRICAN GREEN MONKEY KIDNEY CELLS
    K934243 HUMAN EPIDERMAL CARCINOMA LARYNX CELLS-HEP-2
    K935338 LUNG CACINOMA, HUMAN CELLS
    K934239 KIDNEY AFRICAN GREEN MONKEY CELLS-CV-1
    K935337 RHABDOMYOSARCOMA CELLS
    Search all 19 clearances from ADVANCED CLINICAL DIAGNOSTICS →