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510(k) Data Aggregation

    K Number
    K020914
    Device Name
    ACTALYKE XL ACTIVATED CLOTTING TIME ANALYZER, MODEL 5770
    Manufacturer
    HELENA LABORATORIES
    Date Cleared
    2002-05-23

    (63 days)

    Product Code
    JBP
    Regulation Number
    864.7140
    Type
    Traditional
    Panel
    Hematology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    ACTALYKE XL ACTIVATED CLOTTING TIME ANALYZER, MODEL 5770

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Actalyke XL Activated Clotting Time Analyzer and Test Tubes are indicated for use in the measurement of the activated clotting time test (ACT). This system can be used in bypass surgery, vascular surgery, transplant surgery, cardiac catheterization, and coronary angioplasty.

    Device Description

    Not Found

    AI/ML Overview

    This is an FDA Premarket Notification (510(k)) letter for the Actalyke® XL Analyzer. It does not contain the detailed study information required to complete your request.

    The 510(k) summary (or the full submission, which is not provided here) is where you would typically find the acceptance criteria, study design, and performance data to support substantial equivalence. The letter itself is simply the FDA's decision regarding the premarket notification.

    Therefore, I cannot provide the requested information from the text provided.

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