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FDA 510(k)

AFINION HBALC

K-Number: K050574 · 2005-07-22

ApplicantAxis-Shield Poc AS
Decision Date2005-07-22
Product CodeLCP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

AFINION HBALC is the device name listed in this FDA 510(k) record. The listed applicant is Axis-Shield Poc AS. It received FDA 510(k) clearance on 2005-07-22 under 510(k) number K050574. 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 HBALC?

AFINION HBALC is a medical device that received FDA 510(k) clearance on 2005-07-22. The listed applicant is Axis-Shield Poc AS. The 510(k) number is K050574.

When did AFINION HBALC receive FDA 510(k) clearance?

AFINION HBALC received FDA 510(k) clearance on 2005-07-22, under 510(k) number K050574.

Who is the listed applicant for AFINION HBALC?

The FDA 510(k) record lists Axis-Shield Poc AS as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AFINION HBALC?

The FDA product code for AFINION HBALC is LCP.

Related Clinical Trials

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.

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Other records listing Axis-Shield Poc AS as applicant

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.

K110056AFINION ANALYZERK072409AFINION ACR AND ACR CONTROL

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 SystemQurasenseK214117Afinion™ HbA1c, Afinion™ 2 and Alere Afinion™ AS100 AnalyzerAbbott Diagnostics Technologies ASK192987Aina 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.

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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