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

    FIBRINOGEN RID TEST KIT

    K Number: K922416 · Decision Mar 9, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    27
    Applicant Total
    115
    Review Days
    292

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    Basic Information

    Device Name
    FIBRINOGEN RID TEST KIT
    K Number
    K922416
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.7340
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    The Binding Site, Ltd.
    Date Received
    May 21, 1992
    Decision Date
    March 9, 1993
    Product Code
    KQJ
    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
    KQJ System, Fibrinogen Determination

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