K-number	DEN190056
Device name	ADVIA Centaur Enhanced Liver Fibrosis (ELF)
Applicant	Siemens Healthcare Diagnostics, Inc.
Product code	QQB
Device class	Class II
Decision date	Aug 20, 2021
Decision	Not Substantially Equivalent
Regulation	862.1622

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Source

View the full FDA submission: accessdata.fda.gov

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ADVIA Centaur Enhanced Liver Fibrosis (ELF)

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