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

    HEMOGLOBIN ANALYZER & PERFORM. CHECK SET

    K Number: K771101 · Decision Jul 21, 1977
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    2
    Applicant Total
    26
    Review Days
    31

    Basic Information

    Device Name
    HEMOGLOBIN ANALYZER & PERFORM. CHECK SET
    K Number
    K771101
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.7500
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    THE DOW CHEMICAL CO.
    Date Received
    June 20, 1977
    Decision Date
    July 21, 1977
    Product Code
    GIG
    Advisory Committee
    Hematology
    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
    GIG Hemoglobinometer

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