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510(k) Data Aggregation

    K Number
    K991379
    Device Name
    QUINN'S SPERM WASHING MEDIUM
    Manufacturer
    ADVANCED REPRODUCTIVE TECHNOLOGIES
    Date Cleared
    2000-02-02

    (287 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 :

    QUINN'S SPERM WASHING MEDIUM

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

    Quinn's® Sperm Washing Medium is for in vitro procedures involving sperm washing and incubation.

    Device Description

    Quinn's® Sperm Washing Medium

    AI/ML Overview

    This document is a 510(k) clearance letter for Quinn's® Sperm Washing Medium and an associated "Indications For Use" statement. It does not contain information about acceptance criteria, device performance, study designs, sample sizes, expert qualifications, ground truth establishment, or any comparative effectiveness studies. Therefore, I cannot generate the requested table and study details from the provided text.

    The letter simply states that the FDA has reviewed the 510(k) notification and determined the device is substantially equivalent to legally marketed predicate devices. The "Indications For Use" states that the medium is for in vitro procedures involving sperm washing and incubation.

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