BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇦🇺 Australia

    HAEMOGLOBIN REAGENT - CYANMETHAEMOGLOBIN METHOD

    K Number: K870363 · Decision Mar 16, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    38
    Applicant Total
    55
    Review Days
    47

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    Basic Information

    Device Name
    HAEMOGLOBIN REAGENT - CYANMETHAEMOGLOBIN METHOD
    K Number
    K870363
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.7500
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Trace Scientific , Ltd.
    Date Received
    January 28, 1987
    Decision Date
    March 16, 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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