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

    SYSMEX HEMATOLOGICAL WHOLE BLOOD DILUTING REAGENT-

    K Number: K850239 · Decision Apr 1, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    54
    Registration Numbers
    54
    Same Product Code
    37
    Applicant Total
    33
    Review Days
    69

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    Basic Information

    Device Name
    SYSMEX HEMATOLOGICAL WHOLE BLOOD DILUTING REAGENT-
    K Number
    K850239
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    864.8200
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Toa Medical Electronics USA, Inc.
    Date Received
    January 22, 1985
    Decision Date
    April 1, 1985
    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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