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

    EASY-TEST HEMOGLOBIN (HGB) ITEM #16685

    K Number: K872653 · Decision Jul 23, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    38
    Applicant Total
    288
    Review Days
    16

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    Basic Information

    Device Name
    EASY-TEST HEMOGLOBIN (HGB) ITEM #16685
    K Number
    K872653
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.7500
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Em Diagnostic Systems, Inc.
    Date Received
    July 7, 1987
    Decision Date
    July 23, 1987
    Product Code
    KHG
    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
    KHG Whole Blood Hemoglobin Determination

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