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

    FIBRINOGEN SCREEN

    K Number: K800826 · Decision May 30, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    27
    Applicant Total
    29
    Review Days
    46

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    Basic Information

    Device Name
    FIBRINOGEN SCREEN
    K Number
    K800826
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.7340
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Pacific Hemostasis
    Date Received
    April 14, 1980
    Decision Date
    May 30, 1980
    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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    K991321 PACIFIC HEMOSTASIS THROMBOSCREEN 200
    K990046 PACIFIC HEMOSTASIS IMMUNODEPLETED FACTOR VIII DEFICIENT PLASMA
    K984130 COAGULATION CONTROL LEVEL 2 (ABNORMAL)
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    K984131 COAGULATION CONTROL LEVEL 3 (ABNORMAL)
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