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510(k) Data Aggregation

    K Number
    K040920
    Device Name
    AMYLASE LIQUID REAGENT, MODEL A532-200
    Manufacturer
    TECO DIAGNOSTICS
    Date Cleared
    2004-05-10

    (32 days)

    Product Code
    JFJ
    Regulation Number
    862.1070
    Type
    Special
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    For the quantitative determination of Amylase in human serum and urine. Amylase measurements are used primarily for the diagnostics and treatment of pancreatitis.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a medical device called "Amylase Liquid Reagent" by TECO Diagnostics. It is a regulatory approval document and does not contain information about acceptance criteria or a study proving the device meets those criteria, nor any of the other requested details about a study.

    Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and study details based on the provided text. The letter primarily states that the device is substantially equivalent to a legally marketed predicate device.

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