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

    PACIFIC HEMOSTASIS THROMBO-SCREEN KAPTT

    K Number: K801460 · Decision Jul 28, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    31
    Applicant Total
    29
    Review Days
    34

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    Basic Information

    Device Name
    PACIFIC HEMOSTASIS THROMBO-SCREEN KAPTT
    K Number
    K801460
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.7925
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Pacific Hemostasis
    Date Received
    June 24, 1980
    Decision Date
    July 28, 1980
    Product Code
    GGW
    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
    GGW Test, Time, Partial Thromboplastin

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    Other Clearances by Pacific Hemostasis

    K Number Device Name
    K000679 THROMBOSTRATE CONTROL PLASMAS
    K994100 PACIFIC HEMOSTASIS THROMBOPLASTIN D
    K992130 PACIFIC HEMOSTASIS THROMBOSCREEN 400C
    K992279 HEPARIN CONTROL PLASMA LEVEL 2
    K992278 HEPARIN CONTROL PLASMA LEVEL 1
    K991321 PACIFIC HEMOSTASIS THROMBOSCREEN 200
    K990046 PACIFIC HEMOSTASIS IMMUNODEPLETED FACTOR VIII DEFICIENT PLASMA
    K984130 COAGULATION CONTROL LEVEL 2 (ABNORMAL)
    K984129 COAGULATION CONTROL LEVEL 1 (NORMAL)
    K984131 COAGULATION CONTROL LEVEL 3 (ABNORMAL)
    Search all 29 clearances from Pacific Hemostasis →