FDA 510(k)

Sistema de Análise de Glicohemoglobina A1C EZ

Número K: K161533 · 2017-06-16

Data da decisão2017-06-16

Código do produtoLCP

Comité consultivoHE

DecisãoSubstantially Equivalent

Resumo do dispositivo

A1C EZ Glycohemoglobin Analysis System is the device name listed in this FDA 510(k) record. The listed applicant is Biohermes Co., Ltd.. It received FDA 510(k) clearance on 2017-06-16 under 510(k) number K161533. 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 A1C EZ Glycohemoglobin Analysis System?

A1C EZ Glycohemoglobin Analysis System is a medical device that received FDA 510(k) clearance on 2017-06-16. The listed applicant is Biohermes Co., Ltd.. The 510(k) number is K161533.

When did A1C EZ Glycohemoglobin Analysis System receive FDA 510(k) clearance?

A1C EZ Glycohemoglobin Analysis System received FDA 510(k) clearance on 2017-06-16, under 510(k) number K161533.

Who is the listed applicant for A1C EZ Glycohemoglobin Analysis System?

The FDA 510(k) record lists Biohermes Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for A1C EZ Glycohemoglobin Analysis System?

The FDA product code for A1C EZ Glycohemoglobin Analysis System is LCP.

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