K-number	K210801
Device name	AXINON® LDL-p Test System
Applicant	Numares AG
Product code	MRR
Device class	Class I
Decision date	Jul 19, 2023
Decision	Substantially Equivalent
Regulation	862.1475

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Source

View the full FDA submission: accessdata.fda.gov

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AXINON® LDL-p Test System

Everything you need for a 510(k) submission. Nothing you don't.