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510(k) Data Aggregation

    K Number
    K000679
    Device Name
    THROMBOSTRATE CONTROL PLASMAS
    Manufacturer
    PACIFIC HEMOSTASIS
    Date Cleared
    2000-03-24

    (24 days)

    Product Code
    GGN
    Regulation Number
    864.5425
    Why did this record match?
    Applicant Name (Manufacturer) :

    PACIFIC HEMOSTASIS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K994100
    Device Name
    PACIFIC HEMOSTASIS THROMBOPLASTIN D
    Manufacturer
    PACIFIC HEMOSTASIS
    Date Cleared
    2000-02-18

    (77 days)

    Product Code
    GJS
    Regulation Number
    864.7750
    Why did this record match?
    Applicant Name (Manufacturer) :

    PACIFIC HEMOSTASIS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Pacific Hemostasis Thromboplastin D is an in vitro diagnostic reagent intended for use for the performance of Prothrombin Time (PT) testing and quantitative PT-based factor assays (for Factors II, V, VII and X). Pacific Hemostasis Thromboplastin D is intended for use for performing the one-stage Prothrombin Time test (PT) and PT-based factor assays.
    Device Description
    Pacific Hemostasis Thromboplastin D is a lyophilized extract of rabbit brain thromboplastin containing calcium, stabilizer and buffer.
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    K Number
    K992130
    Device Name
    PACIFIC HEMOSTASIS THROMBOSCREEN 400C
    Manufacturer
    PACIFIC HEMOSTASIS
    Date Cleared
    1999-09-03

    (72 days)

    Product Code
    KQG
    Regulation Number
    864.5400
    Why did this record match?
    Applicant Name (Manufacturer) :

    PACIFIC HEMOSTASIS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Pacific Hemostasis ThromboScreen® 400C is a photo-optical instrument used for the performance of in-vitro diagnostic coagulation testing of citrated plasma samples in the clinical laboratory. The ThromboScreen® 400C has both clot and chromogenic testing capabilities. Assays performed on the instrument include routine clotting tests such as Prothrombin Time (PT), Activated Partial Thromboplastin Time (APTT), Fibrinogen (Clauss and Derived methods), and PT and APTT-based factor assays. Chromogenic tests include assays such as Antithrombin III, Protein C and Heparin Xa.
    Device Description
    The ThromboScreen® 400C (TS400C) is a photo-optical instrument used for the performance of in-vitro diagnostic clotting and chromogenic procedures in the clinical laboratory. The instrument utilizes photo-optical principles for both clotting and chromogenic assays. The ThromboScreen® 400C light source is provided by a halogen lamp. The incubator block is temperature regulated to 36.5 - 37.5℃ and contains four measuring positions, five reagent and 24 cuvette prewarming positions.
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    K Number
    K992278
    Device Name
    HEPARIN CONTROL PLASMA LEVEL 1
    Manufacturer
    PACIFIC HEMOSTASIS
    Date Cleared
    1999-08-26

    (50 days)

    Product Code
    GGN
    Regulation Number
    864.5425
    Why did this record match?
    Applicant Name (Manufacturer) :

    PACIFIC HEMOSTASIS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Pacific Hemostasis Heparin Control Plasma Level 1, an unassayed control plasma, is intended for use in heparin assay procedures. In addition, it can be used for quality control in monitoring heparin therapy with Activated Partial Thromboplastin Time (APTT) testing. It will yield APTT values in the slightly abnormal range.
    Device Description
    Pacific Hemostasis Heparin Control Level 1 is a lyophilized preparation of citrated plasma obtained from healthy donors, which contains sodium heparin, stabilizers and buffers. Each unit of source material used in the preparation of the reagent has been tested by an FDA approved method and found nonreactive for HBsAG and negative for antibodies to HIV and HCV.
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    K Number
    K992279
    Device Name
    HEPARIN CONTROL PLASMA LEVEL 2
    Manufacturer
    PACIFIC HEMOSTASIS
    Date Cleared
    1999-08-26

    (50 days)

    Product Code
    GGN
    Regulation Number
    864.5425
    Why did this record match?
    Applicant Name (Manufacturer) :

    PACIFIC HEMOSTASIS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Pacific Hemostasis Heparin Control Plasma Level 2, an unassayed control plasma, is intended for use in heparin assay procedures. In addition, it can be used for quality control in monitoring heparin therapy with Activated Partial Thromboplastin Time (APTT) testing. It will yield APTT values in the moderately high abnormal range.
    Device Description
    Pacific Hemostasis Heparin Control Level 2 is a lyophilized preparation of citrated plasma obtained from healthy donors, which contains sodium heparin, stabilizers and buffers. Each unit of source material used in the preparation of the reagent has been tested by an FDA approved method and found nonreactive for HBsAG and negative for antibodies to HIV and HCV.
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    K Number
    K991321
    Device Name
    PACIFIC HEMOSTASIS THROMBOSCREEN 200
    Manufacturer
    PACIFIC HEMOSTASIS
    Date Cleared
    1999-06-21

    (63 days)

    Product Code
    KQG
    Regulation Number
    864.5400
    Why did this record match?
    Applicant Name (Manufacturer) :

    PACIFIC HEMOSTASIS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Pacific Hemostasis ThromboScreen® 200 is a photo-optical instrument used for the performance of in-vitro diagnostic coagulation testing of citrated plasma specimens in the clinical laboratory. Coagulation testing capabilities of the device include routine clotting tests such as Prothrombin Time (PT), Activated Partial Thromboplastin Time (APTT), Fibrinogen (Clauss and Derived methods), as well as PT and APTT-based factor assays.
    Device Description
    The ThromboScreen® 200 (TS200) is a photo-optical instrument used for the performance of invitro diagnostic clotting procedures in the clinical laboratory. The instrument utilizes photo-optical principles to measure and record the time required for patient plasma specimens to clot. The ThromboScreen® 200 light source is provided by a 470 nm LASER. The incubator block is temperature regulated to 36.5 - 37.5℃ and contains two measuring positions, three reagent and 12 cuvette prewarming positions.
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    K Number
    K990046
    Device Name
    PACIFIC HEMOSTASIS IMMUNODEPLETED FACTOR VIII DEFICIENT PLASMA
    Manufacturer
    PACIFIC HEMOSTASIS
    Date Cleared
    1999-02-17

    (41 days)

    Product Code
    GJT
    Regulation Number
    864.7290
    Why did this record match?
    Applicant Name (Manufacturer) :

    PACIFIC HEMOSTASIS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Pacific Hemostasis Immunodepleted Factor VIII (FVIII) Deficient Plasma is intended for use as a substrate in the quantitative determination of Factor VIII activity in citrated plasma.
    Device Description
    Pacific Hemostasis (PH) Immunodepleted Factor VIII Deficient Plasma is a lyophilized preparation of fresh human plasma with added stabilizer. The product is prepared from pooled normal citrated plasma, and then depleted of FVIII by immobilized highly specific antibodies. Factor VIII activity is less than 1%, all other coagulation Factors are within the normal range. Each unit of source material used in the preparation of this product has been tested and found negative for HBsAg (Hepatitus B Surface antigen) and negative for antibodies to HIV and HCV. The product is provided in 1.0mL vials, 10 vials per package.
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    K Number
    K984129
    Device Name
    COAGULATION CONTROL LEVEL 1 (NORMAL)
    Manufacturer
    PACIFIC HEMOSTASIS
    Date Cleared
    1998-12-01

    (13 days)

    Product Code
    GIZ
    Regulation Number
    864.5425
    Why did this record match?
    Applicant Name (Manufacturer) :

    PACIFIC HEMOSTASIS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Pacific Hemostasis Coagulation Control Level 1 is intended for use as a control to monitor the performance of routine coagulation assays, i.e. Prothrombin Time (PT), Activated Partial Thromboplastin Time (APTT) and Fibrinogen assays. It will yield PT, APTT and Fibrinogen values in the normal range.
    Device Description
    Pacific Hemostasis Coagulation Control Level 1 (Normal) is a lyophilized preparation of citrated plasma obtained from healthy donors. Stabilizers and buffers have been added to the plasma prior to lyophilization. Each unit of source material used in the preparation of the reagent has been tested by an FDA approved method and found non-reactive for HBsAG and negative for antibodies to HIV and HCV.
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    K Number
    K984130
    Device Name
    COAGULATION CONTROL LEVEL 2 (ABNORMAL)
    Manufacturer
    PACIFIC HEMOSTASIS
    Date Cleared
    1998-12-01

    (13 days)

    Product Code
    GGC
    Regulation Number
    864.5425
    Why did this record match?
    Applicant Name (Manufacturer) :

    PACIFIC HEMOSTASIS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Pacific Hemostasis Coagulation Control Level 2 is intended for use as a control to monitor the performance of Prothrombin Time (PT) and Activated Partial Time (APTT) testing. It will yield PT and APTT values in the moderately abnormal range.
    Device Description
    Pacific Hemostasis Coagulation Control Level 2 (Abnormal) is a lyophilized preparation of citrated plasma obtained from healthy donors, which has been adjusted to yield prolonged Prothrombin Time and Activated Partial Time values. Stabilizers and buffers have been added to the plasma prior to lyophilization. Each unit of source material used in the preparation of the reagent has been tested by an FDA approved method and found non-reactive for HBsAG and negative for antibodies to HIV and HCV.
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    K Number
    K984131
    Device Name
    COAGULATION CONTROL LEVEL 3 (ABNORMAL)
    Manufacturer
    PACIFIC HEMOSTASIS
    Date Cleared
    1998-12-01

    (13 days)

    Product Code
    GGC
    Regulation Number
    864.5425
    Why did this record match?
    Applicant Name (Manufacturer) :

    PACIFIC HEMOSTASIS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Pacific Hemostasis Coagulation Control Level 3 is intended for use as a control to monitor the performance of Prothrombin Time (PT) and Activated Partial Time (APTT) testing. It will yield PT and APTT values in the markedly abnormal range.
    Device Description
    Pacific Hemostasis Coagulation Control Level 3 (Abnormal) is a lyophilized preparation of citrated plasma obtained from healthy donors, which has been adjusted to yield prolonged Prothrombin Time and Activated Partial Thromboplastin Time values. Stabilizers and buffers have been added to the plasma prior to lyophilization. Each unit of source material used in the preparation of the reagent has been tested by an FDA approved method and found non-reactive for HBsAG and negative for antibodies to HIV and HCV.
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