ENTHANOL (RATE) ASSAY, CATALOGUE NO. 219-03

• K Number: K955633
• Device Name: ENTHANOL (RATE) ASSAY, CATALOGUE NO. 219-03
• Manufacturer: DIAGNOSTIC CHEMICALS LTD.
• Date Cleared: 1996-05-24 ( 165 days)
• Product Code: DIC
• Regulation Number: 862.3040
• Type: Traditional
• Panel: TX
• 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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Regulation Number and Section

§ 862.3040 Alcohol test system.

(a)
Identification. An alcohol test system is a device intented to measure alcohol (e.g., ethanol, methanol, isopropanol, etc.) in human body fluids (e.g., serum, whole blood, and urine). Measurements obtained by this device are used in the diagnosis and treatment of alcohol intoxication and poisoning.(b)
Classification. Class II.