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510(k) Data Aggregation

    K Number
    K062604
    Device Name
    RAPIDTEG TEG-ACT TEST
    Manufacturer
    HAEMOSCOPE CORP.
    Date Cleared
    2007-01-31

    (152 days)

    Product Code
    JBP
    Regulation Number
    864.7140
    Why did this record match?
    Applicant Name (Manufacturer) :

    HAEMOSCOPE CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The RapidTEG™ TEG®-ACT Test is a quantitative in vitro diagnostic test intended to monitor heparin anticoagulation in adult patients. It is intended for the use with the Thrombelastograph® (TEG®) Hemostasis System.
    Device Description
    Not Found
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    K Number
    K041502
    Device Name
    THROMBELASTOGRAPH (TEG) PLATELET MAPPING ASSAY
    Manufacturer
    HAEMOSCOPE CORP.
    Date Cleared
    2004-09-01

    (86 days)

    Product Code
    JOZ
    Regulation Number
    864.5700
    Why did this record match?
    Applicant Name (Manufacturer) :

    HAEMOSCOPE CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The TEG® Platelet Mapping Assay is intended for use with the Thrombelastograph (TEG) Hemostasis Analyzer to assess platelet function in patients who have received platelet inhibiting drugs such as aspirin, clopidogrel, abciximab, tirofiban, or eptifibatide.
    Device Description
    The TEG Platelet Mapping Assay consists of a set of blood modifiers, ADP and AA platelet agonists together with ActivatorF, which when used on a heparinized blood sample can measure the inhibition of platelet function.
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    K Number
    K002177
    Device Name
    THROMBELASTOGRAPH COAGULATION ANALYZER TEG-5000 SERIES
    Manufacturer
    HAEMOSCOPE CORP.
    Date Cleared
    2000-09-14

    (57 days)

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

    HAEMOSCOPE CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K993678
    Device Name
    THROMBELASTOGRAPH COAGULATION ANALYZER TEG - 5000 SERIES
    Manufacturer
    HAEMOSCOPE CORP.
    Date Cleared
    2000-05-05

    (186 days)

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

    HAEMOSCOPE CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Thrombelastograph (TEG) Coagulation Analyzer TEG - 5000 Series is a noninvasive diagnostic instrument designed to monitor and analyze the coagulation state of a blood sample in order to assist in the assessment of patient clinical hemostasis conditions. The TEG is indicated for use with adult patients where an evaluation of their blood coagulation properties is desired. Coagulations are commonly used to assess clinical conditions such as post-operative hemorrhage and / or thrombosis during and following cardiovascular surgery, organ transplantation, trauma, and cardiology procedures.
    Device Description
    The TEG - 5000 Series Analyzer consists of a two-column TEG instrument, a computer interface module, software, and disposable sample cups and pins. The TEG measures the clot's physical property by the use of a special stationary cylindrical cup that holds the blood and is oscillated. A pin is suspended in the blood by a torsion wire and is monitored for motion. The torque of the rotation cup is transmitted to the immersed pin only after fibrin-platelet bonding has linked the cup and pin together. The strength of these fibrin-platelet bonds affects the magnitude of the pin motion, such that strong clots move the pin directly in phase with the cup motion. The magnitude of the output is, therefore, directly related to the strength of the formed clot. As the clot retracts or breaks apart, these bonds are broken and the transfer of cup motion is diminished.
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    K Number
    K954437
    Device Name
    THROMBELASTOGRAPH COAGULATION ANALYZER 3000S
    Manufacturer
    HAEMOSCOPE CORP.
    Date Cleared
    1996-01-30

    (130 days)

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

    HAEMOSCOPE CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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