BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    HYCEL QUICK-LYSING HEMOGLOBIN REAGENT

    K Number: K882490 · Decision Jul 25, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    54
    Registration Numbers
    54
    Same Product Code
    37
    Applicant Total
    79
    Review Days
    39

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    Basic Information

    Device Name
    HYCEL QUICK-LYSING HEMOGLOBIN REAGENT
    K Number
    K882490
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    864.8200
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    R&D Systems, Inc.
    Date Received
    June 16, 1988
    Decision Date
    July 25, 1988
    Product Code
    GIF
    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
    GIF Diluent, Blood Cell

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