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

    MODIFIED HEMOGLOBIN REAGENT SET

    K Number: K894951 · Decision Oct 24, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    6
    Applicant Total
    2
    Review Days
    96

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    Basic Information

    Device Name
    MODIFIED HEMOGLOBIN REAGENT SET
    K Number
    K894951
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.7500
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Macomb Biotechnology, Inc.
    Date Received
    July 20, 1989
    Decision Date
    October 24, 1989
    Product Code
    GKK
    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
    GKK Cyanomethemoglobin

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