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

    FIBRINOGENTEST-O

    K Number: K881685 · Decision Aug 9, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    12
    Applicant Total
    17
    Review Days
    112

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    Basic Information

    Device Name
    FIBRINOGENTEST-O
    K Number
    K881685
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.7340
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Diatech, Inc.
    Date Received
    April 19, 1988
    Decision Date
    August 9, 1988
    Product Code
    GIS
    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
    GIS Test, Fibrinogen

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    Other Clearances by Diatech, Inc.

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    K854090 DIATIMER-2 BLOOD PLASMA CLOT TIMING INSTRUMENT
    K842286 DIA T1, T2 & T3
    K841523 OWREN'S VERONAL BUFFERR
    K841462 HEPARIN COAGULATION CONTROL PLASMA 1-
    K841366 DIA FIBRIN
    K841365 DIA REPTIN
    K841461 COAGULATION CONTROL PLASMA LEVEL 1/2/3
    K840802 DIA THROMBIN DIA PLASTIN
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