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510(k) Data Aggregation

    K Number
    K050436
    Device Name
    MS 9/5 HEMATOLOGY ANALYZER
    Manufacturer
    MELET SCHLOESING LABORATORIES USA
    Date Cleared
    2005-07-27

    (155 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 9/5 HEMATOLOGY ANALYZER

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

    The MS 9/5 is a quantitative, automated hematology analyzer that provides a leukocyte differential count for In-Vitro diagnostic use in clinical laboratories.

    Device Description

    Not Found

    AI/ML Overview

    The provided text does not contain detailed information about the acceptance criteria and the study that proves the device meets the acceptance criteria for the MS 9/5 Hematology Analyzer. The document is primarily a 510(k) clearance letter from the FDA, confirming substantial equivalence to a predicate device for marketing purposes. It states the device's indications for use but does not delve into the specific performance study details, acceptance criteria, or ground truth establishment.

    Therefore, I cannot provide the requested information based on the given input.

    What is available from the text:

    • Device Name: MS 9/5 Hematology Analyzer
    • Indications for Use: The MS 9/5 is a quantitative, automated hematology analyzer that provides a leukocyte differential count for In-Vitro diagnostic use in clinical laboratories.
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