K-number	K232624
Device name	CardioPhase® hsCRP
Applicant	Siemens Healthcare Diagnostic Products GmbH
Product code	DCN
Device class	Class II
Decision date	Nov 27, 2023
Decision	Substantially Equivalent
Regulation	866.5270

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Source

View the full FDA submission: accessdata.fda.gov

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CardioPhase® hsCRP

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