EMIT II PLUS ETHYL ALCOHOL ASSAY, MODEL OSR9K229

• K Number: K010960
• Device Name: EMIT II PLUS ETHYL ALCOHOL ASSAY, MODEL OSR9K229
• Manufacturer: SYVA CO., DADE BEHRING, INC.
• Date Cleared: 2001-04-26 ( 27 days)
• Product Code: DIC
• Regulation Number: 862.3040
• Type: Special
• Panel: Toxicology
• Age Range: N/A
• Reference & Predicate Devices: N/A
• Predicate For: K070853 , K071811

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

§ 862.3040 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.