FUTURE DIAGNOSTICS B.V. STAT-ACTH KIT

• K Number: K002638
• Device Name: FUTURE DIAGNOSTICS B.V. STAT-ACTH KIT
• Manufacturer: FUTURE DIAGNOSTICS B.V.
• Date Cleared: 2001-01-17 ( 146 days)
• Product Code: CKG
• Regulation Number: 862.1025
• Type: Traditional
• Panel: Clinical Chemistry
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

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Device Description

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Summary

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Regulation Number and Section

§ 862.1025 Adrenocorticotropic hormone (ACTH) test system.

(a)
Identification. An adrenocorticotropic hormone (ACTH) test system is a device intended to measure adrenocorticotropic hormone in plasma and serum. ACTH measurements are used in the differential diagnosis and treatment of certain disorders of the adrenal glands such as Cushing's syndrome, adrenocortical insufficiency, and the ectopic ACTH syndrome.(b)
Classification. Class II.