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510(k) Data Aggregation

    K Number
    K070251
    Device Name
    CARBON DIOXIDE LIQUID STABLE REAGENT
    Manufacturer
    POINTE SCIENTIFIC, INC.
    Date Cleared
    2007-04-30

    (94 days)

    Product Code
    KHS
    Regulation Number
    862.1160
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    CARBON DIOXIDE LIQUID STABLE REAGENT

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

    This product is to be used for the quantitative determination of carbon dioxide in human serum by spectrophotometric analysis. The determination of the level of carbon dioxide in serum is commonly performed as an indicator of acid-base balance disturbances.

    Device Description

    Carbon Dioxide Liquid Stable Reagent

    AI/ML Overview

    I am sorry, but based on the provided text, there is no information about acceptance criteria, a study proving a device meets acceptance criteria, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, ground truth types, or training set details.

    The text is a regulatory clearance letter from the FDA for a medical device called "Carbon Dioxide Liquid Stable Reagent." It states that the device is substantially equivalent to legally marketed predicate devices and outlines regulatory requirements for marketing. It does not contain any performance study data or details about criteria for such a study.

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