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K Number
K010052
Device Name
RESPIRONICS BILICHEK NON-INVASIVE-100-0800-20; BILIRUBIN ANALYZER
Manufacturer
RESPIRONICS, INC.
Date Cleared
2001-03-19

(70 days)

Product Code
MQM
Regulation Number
862.1113
Type
Abbreviated
Panel
Clinical Chemistry
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

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§ 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.