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510(k) Data Aggregation

    K Number
    K970250
    Device Name
    CLINISTRIP
    Manufacturer
    TECO DIAGNOSTICS
    Date Cleared
    1997-04-08

    (76 days)

    Product Code
    JIL,CDM,CEN,JIN,JIO,JJB,JJR,JMT,JRE,LJX
    Regulation Number
    862.1340
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    CLINISTRIP

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

    Clinistrip 10 SGL are intend to provide semi-quantitative determination of glucose, bilirubin, ketone, specific gravity, blood, pH, protein, urobilinogen, nitrite, & leukocytes in urine. Tast results may provide information ragarding the status of carbohydrate metabolism, kidney & liver function, acid-base balance, & bacteriurea.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter for the TECO Diagnostics CLINISTRIP device, a urinary glucose (nonquantitative) test system. It describes the indications for use of the device but does not contain information about acceptance criteria or a study proving the device meets those criteria.

    Therefore, I cannot provide the requested information. The document focuses on regulatory clearance and substantial equivalence rather than performance data or study details.

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