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FDA 510(k)

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

K-Number: K214117 · 2023-09-27

ApplicantAbbott Diagnostics Technologies AS
Decision Date2023-09-27
Product CodeLCP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

Afinion™ HbA1c, Afinion™ 2 and Alere Afinion™ AS100 Analyzer is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Diagnostics Technologies AS. It received FDA 510(k) clearance on 2023-09-27 under 510(k) number K214117. The device is classified under product code LCP. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Afinion™ HbA1c, Afinion™ 2 and Alere Afinion™ AS100 Analyzer?

Afinion™ HbA1c, Afinion™ 2 and Alere Afinion™ AS100 Analyzer is a medical device that received FDA 510(k) clearance on 2023-09-27. The listed applicant is Abbott Diagnostics Technologies AS. The 510(k) number is K214117.

When did Afinion™ HbA1c, Afinion™ 2 and Alere Afinion™ AS100 Analyzer receive FDA 510(k) clearance?

Afinion™ HbA1c, Afinion™ 2 and Alere Afinion™ AS100 Analyzer received FDA 510(k) clearance on 2023-09-27, under 510(k) number K214117.

Who is the listed applicant for Afinion™ HbA1c, Afinion™ 2 and Alere Afinion™ AS100 Analyzer?

The FDA 510(k) record lists Abbott Diagnostics Technologies AS as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Afinion™ HbA1c, Afinion™ 2 and Alere Afinion™ AS100 Analyzer?

The FDA product code for Afinion™ HbA1c, Afinion™ 2 and Alere Afinion™ AS100 Analyzer is LCP.

Related Devices (Code: LCP)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K221326Nova Allegro HbA1c Assay, Nova Allegro AnalyzerNova Biomedical CorporationK231465Q-Pad Test SystemQurasenseK192987Aina HbA1c Monitoring System 2Jana Care, Inc.K192369PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test KitIxensor Co, Ltd.K183230OneDraw A1C Test SystemDrawbridge Health, Inc.K181915PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test KitIxensor Co, Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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