BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    WHITE BLOOD CELLS HUMAN TAND B

    K Number: K833929 · Decision Feb 3, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    6
    Applicant Total
    2
    Review Days
    108

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    Basic Information

    Device Name
    WHITE BLOOD CELLS HUMAN TAND B
    K Number
    K833929
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.5220
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Control Diagnostics
    Date Received
    October 18, 1983
    Decision Date
    February 3, 1984
    Product Code
    LIZ
    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
    LIZ Assay, T Lymphocyte Surface Marker

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    Other Clearances by Control Diagnostics

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