EMIT 2000 PHENOBARBITAL ASSAY, MODEL OSR4D229

• K Number: K011528
• Device Name: EMIT 2000 PHENOBARBITAL ASSAY, MODEL OSR4D229
• Manufacturer: SYVA CO.
• Date Cleared: 2001-06-06 ( 20 days)
• Product Code: DLZ
• Regulation Number: 862.3660
• Type: Special
• Panel: Clinical Chemistry
• Age Range: N/A
• Reference & Predicate Devices: N/A
• Predicate For: N/A

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

§ 862.3660 Phenobarbital test system.

(a)
Identification. A phenobarbitol test system is a device intended to measure phenobarbital, an antiepileptic and sedative-hypnotic drug, in human specimens. Measurements obtained by this device are used in the diagnosis and treatment of phenobarbital use or overdose and in monitoring levels of phenobarbital to ensure appropriate therapy.(b)
Classification. Class II.