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510(k) Data Aggregation

    K Number
    K012038
    Device Name
    JAS URIC ACID LIQUID REAGENT
    Manufacturer
    JAS Diagnostics, Inc.
    Date Cleared
    2001-08-21

    (53 days)

    Product Code
    KNK,JHB
    Regulation Number
    862.1775
    Type
    Traditional
    Panel
    Clinical Chemistry (CH)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    JAS URIC ACID LIQUID REAGENT

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

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

    Uric Acid measurements are used in the diagnosis and treatment of numerous renal and metabolic disorders, including renal failure, gout, leukemia, psoriasis, starvation or other wasting conditions, and of patients receiving cytotoxic drugs.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but based on the provided document, the information requested in your prompt (acceptance criteria, study details, sample sizes, expert qualifications, etc.) is not available. This document is an FDA 510(k) clearance letter for a Uric Acid Reagent, which states that the device is substantially equivalent to legally marketed devices and can proceed to market. It does not contain details about specific acceptance criteria or a study proving that the device meets those criteria.

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