COLORMATE TLC BILITEST SYSTEM

• K Number: K001687
• Device Name: COLORMATE TLC BILITEST SYSTEM
• Manufacturer: CHROMATICS COLOR SCIENCES INTL., INC.
• Date Cleared: 2001-09-13 ( 469 days)
• Product Code: MQM
• Regulation Number: 862.1113
• 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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AI/ML Overview

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Summary

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Regulation Number and Section

§ 862.1113 Bilirubin (total and unbound) in the neonate test system.

(a)
Identification. A bilirubin (total and unbound) in the neonate test system is a device intended to measure the levels of bilirubin (total and unbound) in the blood (serum) of newborn infants to aid in indicating the risk of bilirubin encephalopathy (kernicterus).(b)
Classification. Class I.