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

    A549 (HUMAN LUNG CARCINOMA) CULTURE CELLS

    K Number: K864776 · Decision Dec 31, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    169
    Applicant Total
    35
    Review Days
    23

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    Basic Information

    Device Name
    A549 (HUMAN LUNG CARCINOMA) CULTURE CELLS
    K Number
    K864776
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    864.2280
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Bartels Immunodiagnostic Supplies, Inc.
    Date Received
    December 8, 1986
    Decision Date
    December 31, 1986
    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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