K-number	K192777
Device name	ADVIA Centaur CA 15-3 assay
Applicant	Siemens Healthcare Diagnostics, Inc.
Product code	MOI
Device class	Class II
Decision date	Nov 22, 2019
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 CA 15-3 assay

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