K-number	K173206
Device name	SEKURE HbA1c Assay
Applicant	Sekisui Diagnostics P.E.I., Inc.
Product code	PDJ
Device class	Class II
Decision date	Jul 12, 2018
Decision	Substantially Equivalent
Regulation	862.1373

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Source

View the full FDA submission: accessdata.fda.gov

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SEKURE HbA1c Assay

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