AMMONIA-L3K ASSAY, CATALOGUE NUMBER 233-10

• K Number: K033921
• Device Name: AMMONIA-L3K ASSAY, CATALOGUE NUMBER 233-10
• Manufacturer: DIAGNOSTIC CHEMICALS LTD.
• Date Cleared: 2004-03-10 ( 83 days)
• Product Code: JIF
• Regulation Number: 862.1065
• Type: Traditional
• Panel: CH
• Reference & Predicate Devices: N/A

Intended Use

For the IN VITRO quantitative determination of Ammonia in plasma. Anmonia measurements are used in the clagaosis and treatment of severe liver disorders, such as circhosis, and Reve s Syndrome. For the IN VITRO quantitative dctermination of Anumonia in plasma

Device Description

Ammonia-L3K @ Assay, Cat. No. 233

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for a device called "Ammonia-L-3K Assay." This type of document is a notification of the agency's decision that the device is substantially equivalent to a predicate device and can be legally marketed. It is not a study report and therefore does not contain information about acceptance criteria or specific study results as requested in the prompt.

Therefore, I cannot provide the requested information based on the provided text. The document focuses on regulatory approval rather than technical performance data.

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.