SYNCHRON SYSTEMS ALCOHOL REAGENT AND CALIBRATORS

• K Number: K000410
• Device Name: SYNCHRON SYSTEMS ALCOHOL REAGENT AND CALIBRATORS
• Manufacturer: BECKMAN COULTER, INC.
• Date Cleared: 2000-04-10 ( 62 days)
• Product Code: DMT
• Regulation Number: 862.3040
• Type: Traditional
• Panel: TX
• Reference & Predicate Devices: 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.