K-number	K182988
Device name	Afinion HbA1c Dx on Afinion 2
Applicant	Alere Technologies AS
Product code	PDJ
Device class	Class II
Decision date	Nov 29, 2018
Decision	Substantially Equivalent
Regulation	862.1373

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Source

View the full FDA submission: accessdata.fda.gov

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Afinion HbA1c Dx on Afinion 2

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