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

    HEMOGLOBIN REAGENT

    K Number: K910745 · Decision Jul 11, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    30
    Registration Numbers
    30
    Same Product Code
    38
    Applicant Total
    33
    Review Days
    140

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    Basic Information

    Device Name
    HEMOGLOBIN REAGENT
    K Number
    K910745
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.5620
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Toa Medical Electronics USA, Inc.
    Date Received
    February 21, 1991
    Decision Date
    July 11, 1991
    Product Code
    GKR
    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
    GKR System, Hemoglobin, Automated

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