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

    HEPARIN/PLATELET FACTOR 4 ANTIBODY SERUM PANEL

    K Number: K052697 · Decision Jan 4, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    43
    Registration Numbers
    43
    Same Product Code
    98
    Applicant Total
    5
    Review Days
    98

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    Basic Information

    Device Name
    HEPARIN/PLATELET FACTOR 4 ANTIBODY SERUM PANEL
    K Number
    K052697
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.5425
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Akers Biosciences, Inc.
    Date Received
    September 28, 2005
    Decision Date
    January 4, 2006
    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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