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

    KING DIAGNOSTICS CHOLESTEROL-FE TEST

    K Number: K811746 · Decision Jul 10, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    5
    Applicant Total
    41
    Review Days
    18

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    Basic Information

    Device Name
    KING DIAGNOSTICS CHOLESTEROL-FE TEST
    K Number
    K811746
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1230
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    King Diagnostics, Inc.
    Date Received
    June 22, 1981
    Decision Date
    July 10, 1981
    Product Code
    CHO
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

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

    Product Code Device Name
    CHO Radioimmunoassay, Cyclic Amp

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