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510(k) Data Aggregation

    K Number
    K020616
    Device Name
    BAYER RAPIDPOINT 405 SYSTEM
    Manufacturer
    BAYER DIAGNOSTICS CORP.
    Date Cleared
    2002-07-17

    (142 days)

    Product Code
    GKR
    Regulation Number
    864.5620
    Type
    Traditional
    Panel
    Hematology
    Reference & Predicate Devices
    K946206
    Why did this record match?
    Device Name :

    BAYER RAPIDPOINT 405 SYSTEM

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

    The Rapidpoint 405 System Co-ox measurement cartridge measures total hemoglobin and hemoglobin fractions and derivatives in arterial, venous and capillary whole blood samples. Hemoglobin fractions and derivatives are listed below: Fractions: tHb, FO2Hb, FCOHb, FMetHb, FHHb

    Device Description

    The Rapidpoint 405 system Co-ox measurement cartridge measures the light from the whole blood at several wavelengths. The measurement cartridge detects and quantifies total hemoglobin (fractions and derivatives) and other related quantifies in the sample. Hemoglobin fractions and dervivatives are listed below: tHb, FO2Hb, FCOHb, FMetHb, FHHb

    AI/ML Overview

    I am sorry, but the provided text does not contain information about acceptance criteria or a study that proves a device meets such criteria. The document is a 510(k) Summary for the Bayer Rapidpoint 405 System, primarily focusing on its device description, technological characteristics, and FDA clearance process.

    Therefore, I cannot provide a response to your request, as the necessary details are not present in the given text.

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