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

Name: FDA 510(k) clearance K214117
Creator: U.S. Food and Drug Administration
Published: 2023-09-27

Substantially Equivalent

Abbott Diagnostics Technologies AS

FDA 510(k) clearance K214117 for Afinion HbA1c, Afinion 2 and Alere Afinion AS100 Analyzer, Substantially Equivalent on 2023-09-27. Applicant: Abbott Diagnostics Technologies AS. Device class: 2.

Clearance details

Applicant: Abbott Diagnostics Technologies AS
Product code: Code LCP
Device class: Class 2
Regulation: 21 CFR 864.7470
Advisory panel: Hematology
Date received: 2021-12-30
Decision date: 2023-09-27
Decision: Substantially Equivalent
Clearance type: Dual Track
Location: Oslo, NO

Download summary PDF View on FDA.gov ↗

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