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

    HEMOSIL LA POSITIVE CONTROL & HEMOSIL LA NEGATIVE CONTROL

    K Number: K113211 · Decision Jan 4, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    43
    Registration Numbers
    43
    Same Product Code
    98
    Applicant Total
    321
    Review Days
    65

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    Basic Information

    Device Name
    HEMOSIL LA POSITIVE CONTROL & HEMOSIL LA NEGATIVE CONTROL
    K Number
    K113211
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.5425
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Instrumentation Laboratory CO
    Date Received
    October 31, 2011
    Decision Date
    January 4, 2012
    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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