BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    HEMOSIL DRVVT SCREEN & HEMOSIL DRVVT CONFIRM

    K Number: K110031 · Decision Aug 24, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12
    Same Product Code
    15
    Applicant Total
    321
    Review Days
    231

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    Basic Information

    Device Name
    HEMOSIL DRVVT SCREEN & HEMOSIL DRVVT CONFIRM
    K Number
    K110031
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    864.8950
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Instrumentation Laboratory CO
    Date Received
    January 5, 2011
    Decision Date
    August 24, 2011
    Product Code
    GIR
    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
    GIR Reagent, Russel Viper Venom

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