K-number	K192369
Device name	PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test Kit
Applicant	Ixensor Co, Ltd.
Product code	LCP
Device class	Class II
Decision date	Oct 29, 2019
Decision	Substantially Equivalent
Regulation	864.7470

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Source

View the full FDA submission: accessdata.fda.gov

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PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test Kit

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