K-number	K200210
Device name	ADVIA Centaur® Total hCG assay
Applicant	Siemens Healthcare Diagnostics, Inc.
Product code	DHA
Device class	Class II
Decision date	Jul 13, 2021
Decision	Substantially Equivalent
Regulation	862.1155

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Source

View the full FDA submission: accessdata.fda.gov

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ADVIA Centaur® Total hCG assay

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