NICHOLS ADVANTAGE CHEMILUMINESCENCE CALCITONIN KIT

• K Number: K964635
• Device Name: NICHOLS ADVANTAGE CHEMILUMINESCENCE CALCITONIN KIT
• Manufacturer: NICHOLS INSTITUTE DIAGNOSTICS
• Date Cleared: 1997-05-21 ( 183 days)
• Product Code: JKR
• Regulation Number: 862.1140
• Type: Traditional
• Panel: CH
• Reference & Predicate Devices: N/A

Intended Use

Get notified when PDF is available

Device Description

Get notified when PDF is available

AI/ML Overview

Get notified when PDF is available

Regulation Number and Section

§ 862.1140 Calcitonin test system.

(a)
Identification. A calcitonin test system is a device intended to measure the thyroid hormone calcitonin (thyrocalcitonin) levels in plasma and serum. Calcitonin measurements are used in the diagnosis and treatment of diseases involving the thyroid and parathyroid glands, including carcinoma and hyperparathyroidism (excessive activity of the parathyroid gland).(b)
Classification. Class II.