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510(k) Data Aggregation
K Number
K010052Manufacturer
Date Cleared
2001-03-19
(70 days)
Product Code
Regulation Number
862.1113Type
AbbreviatedPanel
Clinical ChemistryReference & Predicate Devices
N/A
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Device Name :
RESPIRONICS BILICHEK NON-INVASIVE-100-0800-20; BILIRUBIN ANALYZER
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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