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510(k) Data Aggregation

    K Number
    K992829
    Device Name
    CASCADE LIQUID COAGULATION CONTROL LEVELS 1, 2, AND 3
    Manufacturer
    MEDICAL ANALYSIS SYSTEMS, INC.
    Date Cleared
    1999-11-22

    (91 days)

    Product Code
    GGN
    Regulation Number
    864.5425
    Type
    Traditional
    Panel
    Hematology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    CASCADE™ Liquid Coagulation Control, Levels 1, 2, and 3 is a human plasma based quality control material intended for use in the clinical laboratory as a consistent tool of known concentration for monitoring the performance of coagulation assays (prothrombin time, activated partial thromboplastin time, and fibrinogen assays). The user can compare recovered values with expected ranges and is a means of assuring consistent performance of for use on the MLA 1600 analyzer.

    Device Description

    Not Found

    AI/ML Overview

    This document is a marketing clearance letter from the FDA for a medical device called "CASCADE™ Liquid Coagulation Control, Levels 1, 2, and 3". It does not contain information about the device's acceptance criteria, performance studies, or related details that would typically be found in a clinical study report or a 510(k) summary.

    Therefore, I cannot provide the requested information. The document primarily focuses on the regulatory approval and classification of the device.

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