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

    RABBIT KIDNEY CULTURE CELLS (FIRST PASS)

    K Number: K871033 · Decision Mar 31, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    169
    Applicant Total
    11
    Review Days
    15

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    Basic Information

    Device Name
    RABBIT KIDNEY CULTURE CELLS (FIRST PASS)
    K Number
    K871033
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    864.2280
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Microscan Div. Baxter Healthcare Corp.
    Date Received
    March 16, 1987
    Decision Date
    March 31, 1987
    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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