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510(k) Data Aggregation

    K Number
    K053551
    Device Name
    MICROMANIPULATION MEDIA SYSTEM, LG HYALURONIDASE AND LG PARAFFIN OIL
    Manufacturer
    <GENX> INTL., INC.
    Date Cleared
    2006-05-09

    (140 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 :

    MICROMANIPULATION MEDIA SYSTEM, LG HYALURONIDASE AND LG PARAFFIN OIL

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

    LG Paraffin Oil PG is designed for use as an overlay when culturing in microdrops of media to prevent evaporation and to isolate media from changes of pH and osmolarity. Also for use as an overlay during the micromanipulation techniques of ICSI and assisted hatching.

    Device Description

    Micromanipulation Media System: LG Hyaluronidase, LG Paraffin Oil

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA to International, Inc. for LG Hyaluronidase and LG Paraffin Oil. It grants clearance for these reproductive media and supplements.

    The document does not contain any information regarding acceptance criteria, device performance, a study to prove acceptance criteria, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance. The letter is solely an FDA clearance document and does not detail the testing performed by the manufacturer.

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