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

    HEMOGLOBIN DETERMINATION TEST KIT HGB S-100 & 12

    K Number: K874429 · Decision Feb 4, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    2
    Applicant Total
    5
    Review Days
    99

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    Basic Information

    Device Name
    HEMOGLOBIN DETERMINATION TEST KIT HGB S-100 & 12
    K Number
    K874429
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.7415
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Hf Scientific, Inc.
    Date Received
    October 28, 1987
    Decision Date
    February 4, 1988
    Product Code
    GIQ
    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
    GIQ Hemoglobin S

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