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510(k) Data Aggregation

    K Number
    K971072
    Device Name
    CHOLESTEROL REAGENT
    Manufacturer
    DERMA MEDIA LAB., INC.
    Date Cleared
    1997-06-20

    (88 days)

    Product Code
    CHH
    Regulation Number
    862.1175
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders.

    Device Description

    CHOLESTEROL REAGENT

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for a device named "CHOLESTEROL REAGENT." This document is a regulatory approval and does not contain any information regarding acceptance criteria or a study proving the device meets acceptance criteria.

    The letter states that the device is "substantially equivalent" to predicate devices, which means it has been compared to a device already legally marketed. However, it does not describe the specific performance characteristics, clinical study design, or results that would be expected in a document outlining acceptance criteria and a study to meet them.

    Therefore, I cannot provide the requested information based on the input text.

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