AMMONIA-L3K ASSAY, MODEL 263-17, AMMONIA-L3K ASSAY, MODEL 263-30

• K Number: K001285
• Device Name: AMMONIA-L3K ASSAY, MODEL 263-17, AMMONIA-L3K ASSAY, MODEL 263-30
• Manufacturer: DIAGNOSTIC CHEMICALS LTD.
• Date Cleared: 2000-06-02 ( 42 days)
• Product Code: JIF
• Regulation Number: 862.1065
• Type: Traditional
• Panel: Clinical Chemistry
• Age Range: N/A
• 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

§ 862.1065 Ammonia test system.

(a)
Identification. An ammonia test system is a device intended to measure ammonia levels in blood, serum, and plasma, Ammonia measurements are used in the diagnosis and treatment of severe liver disorders, such as cirrhosis, hepatitis, and Reye's syndrome.(b)
Classification. Class I.