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  • Title: Medical Devices; Exemption From Premarket Notification: Method, Metallic Reduction, Glucose (Urinary, Nonquantitative) Test System in a Reagent Tablet Format. Final order.
    Author: Food and Drug Administration, HHS.
    Journal: Fed Regist; 2016 Oct 04; 81(192):68293-5. PubMed ID: 27731614.
    Abstract:
    The Food and Drug Administration (FDA) is publishing an order denying a petition requesting exemption from the premarket notification requirements for "method, metallic reduction, glucose (urinary, nonquantitative)'' devices that are in a reagent tablet format and are classified as class II devices as urinary glucose (nonquantitative) test system (hereinafter referred to as copper reduction tablet test"). Urinary glucose (nonquantitative) measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, hypoglycemia, and hyperglycemia. FDA is publishing this order in accordance with procedures established by the Food and Drug Administration Modernization Act of 1997 (FDAMA).
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