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    K Number
    K092578
    Device Name
    LIFEGLOBAL PROTEIN SUPPLEMENT
    Manufacturer
    GENX INTL., INC.
    Date Cleared
    2010-04-05

    (227 days)

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

    LIFEGLOBAL PROTEIN SUPPLEMENT

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

    LifeGlobal Protein Supplement is intended for use in assisted reproductive procedures that require protein supplementation. These procedures include in vitro fertilization, embryo culture and growth and embryo cryopreservation.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain information about acceptance criteria or a study proving device performance as it is a 510(k) clearance letter for a medical device called "LifeGlobal Protein Supplement". It primarily focuses on the regulatory approval and indications for use of the product. Therefore, I cannot extract the requested information to fill your table or answer your specific questions about study design and results.

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