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

    INRATIO2 PI/NR MONITORING SYSTEM; INRATIO PT/INR TEST STRIP

    K Number: K110212 · Decision May 1, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    31
    Registration Numbers
    31
    Same Product Code
    126
    Applicant Total
    1
    Review Days
    462

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    Basic Information

    Device Name
    INRATIO2 PI/NR MONITORING SYSTEM; INRATIO PT/INR TEST STRIP
    K Number
    K110212
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.7750
    Medical Specialty
    Hematology
    Decision
    Unknown
    Statement or Summary
    Summary
    Applicant
    Alere San Diego, Inc (Formally Biosite Incorporate
    Date Received
    January 25, 2011
    Decision Date
    May 1, 2012
    Product Code
    GJS
    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
    GJS Test, Time, Prothrombin

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