NEONATAL CHEMISTRY SYSTEM, GALACTOSE TEST KIT

• K Number: K950481
• Device Name: NEONATAL CHEMISTRY SYSTEM, GALACTOSE TEST KIT
• Manufacturer: ISOLAB, INC.
• Date Cleared: 1996-02-01 ( 363 days)
• Product Code: JIA
• Regulation Number: 862.1310
• Type: Traditional
• 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

§ 862.1310 Galactose test system.

(a)
Identification. A galactose test system is a device intended to measure galactose in blood and urine. Galactose measurements are used in the diagnosis and treatment of the hereditary disease galactosemia (a disorder of galactose metabolism) in infants.(b)
Classification. Class I.