FDA 510(k)

Alere Afinion HbA1c e ACR no analisador Afinion 2

Número K: K171650 · 2017-11-21

Data da decisão2017-11-21

Código do produtoLCP

Comité consultivoHE

DecisãoSubstantially Equivalent

Resumo do dispositivo

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.

Perguntas frequentes

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.

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