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

    MCCOY CELLS

    K Number: K834119 · Decision Mar 22, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    169
    Applicant Total
    35
    Review Days
    114

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    Basic Information

    Device Name
    MCCOY CELLS
    K Number
    K834119
    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
    November 29, 1983
    Decision Date
    March 22, 1984
    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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