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

    SDI PREPAX DILUKIT CT

    K Number: K840043 · Decision Feb 10, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    54
    Registration Numbers
    54
    Same Product Code
    37
    Applicant Total
    7
    Review Days
    35

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    Basic Information

    Device Name
    SDI PREPAX DILUKIT CT
    K Number
    K840043
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    864.8200
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Scientific Distributors, Inc.
    Date Received
    January 6, 1984
    Decision Date
    February 10, 1984
    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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    Other Clearances by Scientific Distributors, Inc.

    K Number Device Name
    K892658 SDI PREPAX COUNTAPETTE KIT
    K851320 SDI PREPAX DILUKIT M.
    K840044 SDI PREPAX DILUKIT 29-1000
    K840041 SDI PREPAX DILUKIT HW
    K840042 SDI PREPAX DILUKIT CA
    K840038 PREPAX DILUKIT PLUS