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510(k) Data Aggregation

    K Number
    K012332
    Device Name
    JAS CARBON DIOXIDE LIQUID REAGENT
    Manufacturer
    JAS Diagnostics, Inc.
    Date Cleared
    2001-09-06

    (45 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 :

    JAS CARBON DIOXIDE LIQUID REAGENT

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

    Intended for the In Vitro, quantitative determination of carbon dioxide in human serum on automated chemistry analyzers.

    Carbon dioxide measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA regarding a JAS Carbon Dioxide Liquid Reagent. This document approves the device but does not contain the acceptance criteria or the study details that prove the device meets those criteria.

    Therefore, I cannot provide the requested information based on the given text. The text only confirms the device's classification and allows its marketing based on substantial equivalence to a predicate device, but it does not detail the performance study findings or acceptance criteria.

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