K-number	K162281
Device name	CAPI 3 Hb A1c, MULTI-SYSTEM Hb A1C CAPILLARY CONTROLS (2)
Applicant	Sebia
Product code	LCP
Device class	Class II
Decision date	Feb 17, 2017
Decision	Substantially Equivalent
Regulation	864.7470

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View the full FDA submission: accessdata.fda.gov

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CAPI 3 Hb A1c, MULTI-SYSTEM Hb A1C CAPILLARY CONTROLS (2)

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