MODIFICATION TO EMIT 2000 THEOPHYLLINE ASSAY, MODEL OSR 4P229

• K Number: K011166
• Device Name: MODIFICATION TO EMIT 2000 THEOPHYLLINE ASSAY, MODEL OSR 4P229
• Manufacturer: SYVA CO., DADE BEHRING, INC.
• Date Cleared: 2001-05-10 ( 24 days)
• Product Code: KLS
• Regulation Number: 862.3880
• Type: Special
• 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

§ 862.3880 Theophylline test system.

(a)
Identification. A theophylline test system is a device intended to measure theophylline (a drug used for stimulation of the muscles in the cardiovascular, respiratory, and central nervous systems) in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of theophylline overdose or in monitoring levels of theophylline to ensure appropriate therapy.(b)
Classification. Class II.