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510(k) Data Aggregation

    K Number
    K013078
    Device Name
    ACTALYKE MINI ACTIVATED CLOTTING TIME TEST SYSTEM, MODEL 5750/5752
    Manufacturer
    HELENA LABORATORIES
    Date Cleared
    2002-01-10

    (118 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 MINI ACTIVATED CLOTTING TIME TEST SYSTEM, MODEL 5750/5752

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

    ActalykeR Mini™ Activated Clotting Time (ACT) Test System is used to perform the activated clotting time test, a whole blood coagulation assay commonly used to monitor heparin anticoagulation during various medical and surgical procedures. This unit is intended for use in a near-patient or patient-care environment.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for the Actalyke Mini device. It does not contain the specific details about acceptance criteria or a study that proves the device meets those criteria. The letter primarily focuses on the device's substantial equivalence to a legally marketed predicate device and regulatory compliance.

    Therefore, I cannot extract the requested information from the provided document.

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