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510(k) Data Aggregation

    K Number
    K042421
    Device Name
    URITEK 151 URINE ANALYZER, MODEL TC-151
    Manufacturer
    TECO DIAGNOSTICS
    Date Cleared
    2005-05-09

    (244 days)

    Product Code
    KQO,CDM,CEN,JIL,JIN,JIO,JIR,JJB,JMT,JRE,LJX
    Regulation Number
    862.2900
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Uritek-151 Urine Analyzer is intended for use with Teco Urine Reagent Strips for Urinalysis The Offick 19 Print Thialy Lermination of glucose, protein, pH, bilirubin, blood, ketone, urobilinogen, nitrite, specific gravity, and leukocytes in urine.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter for a medical device (Uritek-151 Urine Analyzer) and does not contain the detailed information required to describe acceptance criteria and a study proving the device meets those criteria. The letter confirms that the device is substantially equivalent to a predicate device and can be marketed, but it does not include the actual study data, acceptance criteria, or performance metrics.

    Therefore, I cannot provide the requested information based on the provided text. The document is essentially an FDA approval letter, not a scientific study report.

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