K-number	K200215
Device name	ADVIA Centaur CEA Assay
Applicant	Siemens Healthcare Disgnostics, Inc.
Product code	DHX
Device class	Class II
Decision date	Apr 13, 2020
Decision	Substantially Equivalent
Regulation	866.6010

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Source

View the full FDA submission: accessdata.fda.gov

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ADVIA Centaur CEA Assay

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