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

    FIBRINOGEN TEST

    K Number: K834571 · Decision Feb 4, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    27
    Applicant Total
    17
    Review Days
    37

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    Basic Information

    Device Name
    FIBRINOGEN TEST
    K Number
    K834571
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.7340
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Diatech, Inc.
    Date Received
    December 29, 1983
    Decision Date
    February 4, 1984
    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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    Other Clearances by Diatech, Inc.

    K Number Device Name
    K881685 FIBRINOGENTEST-O
    K854938 COASCREENER/DIASCREENERBLOOD PLASMA TIMING INST.
    K854089 DIATIMER-1 BLOOD PLASMA CLOT TIMING INSTRUMENT
    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
    Search all 17 clearances from Diatech, Inc. →