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

    FIBRON-1, FIBRON-4, QUIKCOAG, FIBRON

    K Number: K021976 · Decision Oct 25, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    13
    Applicant Total
    5
    Review Days
    130

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    Basic Information

    Device Name
    FIBRON-1, FIBRON-4, QUIKCOAG, FIBRON
    K Number
    K021976
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.5400
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Vital Scientific N.V.
    Date Received
    June 17, 2002
    Decision Date
    October 25, 2002
    Product Code
    KQG
    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
    KQG Instrument, Coagulation

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