Name: Predicase
Price: 199 USD

K-number	K214117
Device name	Afinion HbA1c, Afinion 2 and Alere Afinion AS100 Analyzer
Applicant	Abbott Diagnostics Technologies AS
Product code	LCP
Device class	Class II
Decision date	Sep 27, 2023
Decision	Substantially Equivalent
Regulation	864.7470

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Source

View the full FDA submission: accessdata.fda.gov

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Afinion HbA1c, Afinion 2 and Alere Afinion AS100 Analyzer

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

Afinion HbA1c, Afinion 2 and Alere Afinion AS100 Analyzer