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

    LYMPHOCYTE TYPING, POSITIVE CONTROL

    K Number: K761009 · Decision Apr 6, 1977
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    4
    Applicant Total
    44
    Review Days
    155

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    Basic Information

    Device Name
    LYMPHOCYTE TYPING, POSITIVE CONTROL
    K Number
    K761009
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    864.7675
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Hyland Therapeutic Div., Travenol Laboratories
    Date Received
    November 2, 1976
    Decision Date
    April 6, 1977
    Product Code
    LGO
    Advisory Committee
    Hematology
    Review Advisory Committee
    HE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LGO Test, Leukocyte Typing

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