BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    AUTOMATED BLOOD CELL SEPAR. DISP. SFTWR

    K Number: K820396 · Decision Apr 27, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    39
    Registration Numbers
    39
    Same Product Code
    9
    Applicant Total
    1
    Review Days
    75

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    Basic Information

    Device Name
    AUTOMATED BLOOD CELL SEPAR. DISP. SFTWR
    K Number
    K820396
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.9245
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Pheragen Technology Corp.
    Date Received
    February 11, 1982
    Decision Date
    April 27, 1982
    Product Code
    GKT
    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
    GKT Separator, Automated, Blood Cell, Diagnostic

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