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

    HYCEL DILUTOR, VARIOUS MODELS/MULTI

    K Number: K842747 · Decision Oct 1, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    13
    Applicant Total
    79
    Review Days
    80

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    Basic Information

    Device Name
    HYCEL DILUTOR, VARIOUS MODELS/MULTI
    K Number
    K842747
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    864.5240
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    R&D Systems, Inc.
    Date Received
    July 13, 1984
    Decision Date
    October 1, 1984
    Product Code
    GKH
    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
    GKH Apparatus, Automated Blood Cell Diluting

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