NICHOLS ADVANTAGE CHEMILUMINESCENCE CORTISOL KIT

• K Number: K962208
• Device Name: NICHOLS ADVANTAGE CHEMILUMINESCENCE CORTISOL KIT
• Manufacturer: NICHOLS INSTITUTE DIAGNOSTICS
• Date Cleared: 1997-04-08 ( 302 days)
• Product Code: CGR
• Regulation Number: 862.1205
• Type: Traditional
• Panel: Clinical Chemistry
• Age Range: N/A
• Reference & Predicate Devices: N/A
• Predicate For: K984520

Intended Use

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Device Description

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Summary

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Regulation Number and Section

§ 862.1205 Cortisol (hydrocortisone and hydroxycorticosterone) test system.

(a)
Identification. A cortisol (hydrocortisone and hydroxycorticosterone) test system is a device intended to measure the cortisol hormones secreted by the adrenal gland in plasma and urine. Measurements of cortisol are used in the diagnosis and treatment of disorders of the adrenal gland.(b)
Classification. Class II.