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    K Number
    K083509
    Device Name
    LIFEGLOBAL HUMAN SERUM ALBUMIN LG HSA
    Manufacturer
    GENX INTL., INC.
    Date Cleared
    2009-04-24

    (149 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 HUMAN SERUM ALBUMIN LG HSA

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

    LifeGlobal ® Human Serum Albumin (HSA) 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

    The provided text is a clearance letter from the FDA for a medical device called "LifeGlobal® Human Serum Albumin LG HSA." It does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.

    Therefore, I cannot extract the requested information from this document. This document is a regulatory approval, not a technical report or study summary.

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