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

    George King Coumadin Plasma

    K Number: K161316 · Decision Feb 23, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    43
    Registration Numbers
    43
    Same Product Code
    98
    Applicant Total
    5
    Review Days
    288

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    Basic Information

    Device Name
    George King Coumadin Plasma
    K Number
    K161316
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.5425
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    George King Bio-Medical, Inc.
    Date Received
    May 11, 2016
    Decision Date
    February 23, 2017
    Product Code
    GGN
    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
    GGN Plasma, Coagulation Control

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    Other Clearances by George King Bio-Medical, Inc.

    K Number Device Name
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    K945855 A-FACT, ABNORMAL FACTOR ASSAY CONTROL
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