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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
TX
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

§ 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.