EKTACHEM CLINICAL CHEMISTRY UREA NITROGEN/UREA (BUN/UREA)

• K Number: K961196
• Device Name: EKTACHEM CLINICAL CHEMISTRY UREA NITROGEN/UREA (BUN/UREA)
• Manufacturer: JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC.
• Date Cleared: 1996-05-15 ( 49 days)
• Product Code: CDN
• Regulation Number: 862.1770
• Type: Traditional
• Panel: Clinical Chemistry
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

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Device Description

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AI/ML Overview

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Summary

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Regulation Number and Section

§ 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.