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510(k) Data Aggregation

    K Number
    K041600
    Device Name
    QWIKCHECK-BEADS
    Manufacturer
    MEDICAL ELECTRONICS SYSTEMS LTD.
    Date Cleared
    2004-07-27

    (43 days)

    Product Code
    NRF,JJW
    Regulation Number
    864.8625
    Type
    Traditional
    Panel
    Hematology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDICAL ELECTRONICS SYSTEMS LTD.

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

    QwikCheck-beads™ is intended for in-vitro diagnostic use as sperm concentration quality control material for the SQA-V system (MES Ltd., Israel) in both the automated and manual visualization modes, as well as non-instrumented sperm cell counting chambers such as the hemacytometer (Neubauer type), and the non-dilutional chamber (Makler type).

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) premarket notification approval letter for the QwikCheck-beads™ device. It signifies that the device has been found substantially equivalent to existing devices. However, this document does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

    The letter focuses on regulatory approval, classification, and general controls. It does not include details about performance studies, sample sizes, ground truth establishment, or expert evaluations. Therefore, I cannot generate the requested table and study details.

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