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

    TECHNICON H.1 SYSTEM, T LYMPHOCYTES METHOD

    K Number: K860830 · Decision Sep 8, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    6
    Applicant Total
    157
    Review Days
    187

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    Basic Information

    Device Name
    TECHNICON H.1 SYSTEM, T LYMPHOCYTES METHOD
    K Number
    K860830
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.5220
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent for Some Indications
    Applicant
    Technicon Instruments Corp.
    Date Received
    March 5, 1986
    Decision Date
    September 8, 1986
    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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