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

    AMICUS Separator System, AMICUS Separator System; Refurbished

    K Number: K162462 · Decision Nov 23, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    39
    Registration Numbers
    39
    Same Product Code
    9
    Applicant Total
    2
    Review Days
    82

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    Basic Information

    Device Name
    AMICUS Separator System, AMICUS Separator System; Refurbished
    K Number
    K162462
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.9245
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Fresenius Kabi USA,Llc
    Date Received
    September 2, 2016
    Decision Date
    November 23, 2016
    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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    Other Clearances by Fresenius Kabi USA,Llc

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