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

    SDI PREPAX COUNTAPETTE KIT

    K Number: K892658 · Decision May 24, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    0
    Applicant Total
    7
    Review Days
    41

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    Basic Information

    Device Name
    SDI PREPAX COUNTAPETTE KIT
    K Number
    K892658
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    864.8200
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Scientific Distributors, Inc.
    Date Received
    April 13, 1989
    Decision Date
    May 24, 1989
    Product Code
    JCG
    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
    JCG Fluid, Diluting, Manual Cell

    Other Clearances by Scientific Distributors, Inc.

    K Number Device Name
    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
    K840043 SDI PREPAX DILUKIT CT