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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 a medical device manufactured by Abbott Rapid Diagnostics. It received FDA 510(k) clearance on 2017-11-21 under approval 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. It is manufactured by Abbott Rapid Diagnostics. The 510(k) number is K171650.

When was Alere Afinion HbA1c and ACR on Afinion 2 analyzer approved by the FDA?

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

What company makes Alere Afinion HbA1c and ACR on Afinion 2 analyzer?

Alere Afinion HbA1c and ACR on Afinion 2 analyzer is manufactured by Abbott Rapid Diagnostics.

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)

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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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