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510(k) Data Aggregation

    K Number
    K143498
    Device Name
    LifeGlobal Global HP
    Manufacturer
    LifeGlobal Group, LLC
    Date Cleared
    2015-01-20

    (41 days)

    Product Code
    MQL
    Regulation Number
    884.6180
    Type
    Traditional
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    LifeGlobal Global HP

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

    Culture of human embryos from zygote to blastocyst, embryo transfer.

    Device Description

    Not Found

    AI/ML Overview

    The provided text from the FDA 510(k) clearance letter for the LifeGlobal Global HP does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria.

    The document is a clearance letter stating that the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed. It outlines regulatory requirements, but it does not include details of a performance study or acceptance criteria.

    Therefore, I cannot provide the requested information based on the given text.

    To provide this information, I would need access to the full 510(k) submission document, specifically the sections detailing performance data, clinical studies, or non-clinical testing.

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