K-number	K171650
Device name	Alere Afinion HbA1c and ACR on Afinion 2 analyzer
Applicant	Abbott Rapid Diagnostics
Product code	LCP
Device class	Class II
Decision date	Nov 21, 2017
Decision	Substantially Equivalent
Regulation	864.7470

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Source

View the full FDA submission: accessdata.fda.gov

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Alere Afinion HbA1c and ACR on Afinion 2 analyzer

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