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

    HELA HELA EPITHELOID CARCINOMA

    K Number: K935339 · Decision Jan 3, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    169
    Applicant Total
    19
    Review Days
    59

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    Basic Information

    Device Name
    HELA HELA EPITHELOID CARCINOMA
    K Number
    K935339
    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
    November 5, 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

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    Other Clearances by Advanced Clinical Diagnostics

    K Number Device Name
    K936171 TRANSFORMED PRIMARY HUMAN EMBRYONAL KIDNEY
    K936172 RHESUS MONKEY KIDNEY CELLS (LLC-MK2)
    K936169 RHESUS MONKEY KIDNEY CELLS
    K934973 HELA-229/HELA CELLS
    K934934 RABBIT KIDNEY CELLS - R.K.C.
    K935766 PRIMARY AFRICAN GREEN MONKEY KIDNEY CELLS
    K935336 CYNOMOLOGUS MONKEY KIDNEY CELLS
    K934241 MCCOY CULTURE CELLS-MCCOY
    K934243 HUMAN EPIDERMAL CARCINOMA LARYNX CELLS-HEP-2
    K934246 LUNG DIPLOID HUMAN CELLS-WI-38
    Search all 19 clearances from Advanced Clinical Diagnostics →