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

    CONTROL TM 8

    K Number: K823794 · Decision Jan 14, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    9
    Applicant Total
    39
    Review Days
    29

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    Basic Information

    Device Name
    CONTROL TM 8
    K Number
    K823794
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.8625
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    General Diagnostics
    Date Received
    December 16, 1982
    Decision Date
    January 14, 1983
    Product Code
    GLQ
    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
    GLQ Mixture, Control, White-Cell And Red-Cell Indices

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