510(k) K214117— Afinion HbA1c, Afinion 2 and Alere Afinion AS100 Analyzer

Substantially Equivalent

Abbott Diagnostics Technologies AS

Clearance details

Applicant: Abbott Diagnostics Technologies AS
Product code: Code LCP
Advisory panel: Hematology
Date received: 2021-12-30
Decision date: 2023-09-27
Decision: Substantially Equivalent
Clearance type: Dual Track
Location: Oslo, NO

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