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510(k) Data Aggregation

    K Number
    K050421
    Device Name
    MS 4/5 HEMATOLOGY ANALYZER
    Manufacturer
    MELET SCHLOESING LABORATORIES USA
    Date Cleared
    2005-08-31

    (194 days)

    Product Code
    GKZ
    Regulation Number
    864.5220
    Type
    Abbreviated
    Panel
    Hematology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    MS 4/5 HEMATOLOGY ANALYZER

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

    The MS 4/5 is a quantitative, automated hematology analyzer that provides a leukocyte differential for in vitro diagnostic use in clinical laboratories.

    Device Description

    Not Found

    AI/ML Overview

    The provided texts are from a 510(k) premarket notification for the MS 4/5 Hematology Analyzer, primarily containing the FDA's response and the Indications for Use statement. It does not contain the detailed acceptance criteria and study information that would typically be found in the manufacturer's submission for device performance.

    Therefore, I cannot provide the requested information from these documents. To answer your questions, I would need the actual study report or the sections of the 510(k) submission that detail the performance testing and acceptance criteria for the MS 4/5 Hematology Analyzer.

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