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K Number
K971477
Device Name
UREA (UREA NITROGEN) - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY (DST)
Manufacturer
TRACE AMERICA, INC.
Date Cleared
1997-05-27

(34 days)

Product Code
CDQ,CDO
Regulation Number
862.1770
Type
Traditional
Panel
CH
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Intended for the In Vitro, quantitative determination of Urea Nitrogen) in human serum and urine for clinical diagnosis.

"This Urea (Urea Nitrogen) test system is a device intended to measure urea nitrogen (an end-product of nitrogen metabolism) in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of certain renal and metabolic diseases." CFR 862.1770

Device Description

TRACE Urea (Urea Nitrogen) - DST Reagent

AI/ML Overview

This document is a 510(k) premarket notification approval letter from the FDA for a medical device. It does not contain information about the acceptance criteria or a study proving the device meets said criteria. Therefore, I cannot extract the requested information from this document.

§ 862.1770 Urea nitrogen test system.

(a)
Identification. A urea nitrogen test system is a device intended to measure urea nitrogen (an end-product of nitrogen metabolism) in whole blood, serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of certain renal and metabolic diseases.(b)
Classification. Class II.