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510(k) Data Aggregation

    K Number
    K981824
    Device Name
    OPTICOAT T3 EIA KIT
    Manufacturer
    BIOTECX LABORATORIES, INC.
    Date Cleared
    1998-12-22

    (214 days)

    Product Code
    CDP
    Regulation Number
    862.1710
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    OPTICOAT T3 EIA KIT

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

    A total triiodothyronine test system is a device intended to measure the hormone triiodothyronine in serum. Measurements obtained by this device are used in the diagnosis and treatment of thyroid diseases such as hyperthyroidism.

    Device Description

    Not Found

    AI/ML Overview

    This document is an FDA 510(k) clearance letter for the OptiCoat™ T3 EIA Kit, dated December 22, 1998. It primarily addresses the regulatory approval of the device and does not contain detailed information about the acceptance criteria or the specific study that proves the device meets those criteria.

    Therefore, I cannot provide the requested information based on the provided text. The document confirms that the device is "substantially equivalent" to legally marketed predicate devices, which is the basis for its market clearance, but it does not include the performance data of the device itself.

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