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FDA 510(k)

Alere Afinion HbA1c and ACR on Afinion 2 analyzer

K-Number: K171650 · 2017-11-21

ApplicantAbbott Rapid Diagnostics
Decision Date2017-11-21
Product CodeLCP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

Alere Afinion HbA1c and ACR on Afinion 2 analyzer is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Rapid Diagnostics. It received FDA 510(k) clearance on 2017-11-21 under 510(k) number K171650. 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 Alere Afinion HbA1c and ACR on Afinion 2 analyzer?

Alere Afinion HbA1c and ACR on Afinion 2 analyzer is a medical device that received FDA 510(k) clearance on 2017-11-21. The listed applicant is Abbott Rapid Diagnostics. The 510(k) number is K171650.

When did Alere Afinion HbA1c and ACR on Afinion 2 analyzer receive FDA 510(k) clearance?

Alere Afinion HbA1c and ACR on Afinion 2 analyzer received FDA 510(k) clearance on 2017-11-21, under 510(k) number K171650.

Who is the listed applicant for Alere Afinion HbA1c and ACR on Afinion 2 analyzer?

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

What is the FDA product code for Alere Afinion HbA1c and ACR on Afinion 2 analyzer?

The FDA product code for Alere Afinion HbA1c and ACR on Afinion 2 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 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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