LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

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
    Type
    Traditional
    Panel
    Hematology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    RAPIDTEG TEG-ACT TEST

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    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

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA. It does not contain the detailed acceptance criteria or the study information requested. The letter only states that the device is substantially equivalent to legally marketed predicate devices.

    Therefore, I cannot provide the requested information from the given input.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1