DIMENSION ENZYMATIC CARBONATE (ECO2) FLEX METHOD, CATALOG DF137

• K Number: K010206
• Device Name: DIMENSION ENZYMATIC CARBONATE (ECO2) FLEX METHOD, CATALOG DF137
• Manufacturer: DADE BEHRING, INC.
• Date Cleared: 2001-03-16 ( 52 days)
• Product Code: KHS
• Regulation Number: 862.1160
• Type: Traditional
• Panel: CH
• 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

§ 862.1160 Bicarbonate/carbon dioxide test system.

(a)
Identification. A bicarbonate/carbon dioxide test system is a device intended to measure bicarbonate/carbon dioxide in plasma, serum, and whole blood. Bicarbonate/carbon dioxide measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance.(b)
Classification. Class II.