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510(k) Data Aggregation

    K Number
    K022330
    Device Name
    ALLGRAD 45 AND 90 CELL SEPARATION MEDIA
    Manufacturer
    <GENX> INTL., INC.
    Date Cleared
    2002-08-26

    (39 days)

    Product Code
    MQL
    Regulation Number
    884.6180
    Type
    Traditional
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    AllGrad 45 and 90 cell separation media by is intended for use in assisted reproduction techniques.

    Device Description

    ALLGrad™ Cell Separation Media 45% and 90% Density Gradient Solution

    AI/ML Overview

    This is a letter to the submitter of a 510(k) premarket notification and does not contain the requested information about acceptance criteria or study details. The letter grants clearance for the device "AllGrad™ 45 and 90 cell separation media" for use in assisted reproduction techniques based on substantial equivalence to legally marketed predicate devices.

    Therefore, I cannot provide the requested table or study details based on the provided text.

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