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510(k) Data Aggregation

    K Number
    K023033
    Device Name
    ALLGRAD WASH (HERPES BUFFERED WASHING MEDIUM)
    Manufacturer
    <GENX> INTL., INC.
    Date Cleared
    2002-11-26

    (75 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 :

    ALLGRAD WASH (HERPES BUFFERED WASHING MEDIUM)

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

    AllGrad Wash is used for sperm washing procedures such as in vitro washing and incubation of sperm in Assisted Reproduction techniques

    Device Description

    Not Found

    AI/ML Overview

    The provided document is a 510(k) premarket notification letter from the FDA for a device called "AllGrad Wash (Hepes Buffered Wash Medium)." This document does not describe acceptance criteria, a study that proves the device meets those criteria, or any details about AI/ML algorithms, sample sizes, ground truth, or expert adjudications.

    It is a regulatory clearance document for a reproductive media product, not an AI/ML-driven medical device. Therefore, I cannot extract the requested information from this document.

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