FDA 510(k)

Lucica Glycated Albumin-L

Número K: K170147 · 2017-10-12

RequerenteAsahi Kasei Pharma Corporation

Data da decisão2017-10-12

Código do produtoLCP

Comité consultivoHE

DecisãoSubstantially Equivalent

Resumo do dispositivo

Lucica Glycated Albumin-L is the device name listed in this FDA 510(k) record. The listed applicant is Asahi Kasei Pharma Corporation. It received FDA 510(k) clearance on 2017-10-12 under 510(k) number K170147. 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 Lucica Glycated Albumin-L?

Lucica Glycated Albumin-L is a medical device that received FDA 510(k) clearance on 2017-10-12. The listed applicant is Asahi Kasei Pharma Corporation. The 510(k) number is K170147.

When did Lucica Glycated Albumin-L receive FDA 510(k) clearance?

Lucica Glycated Albumin-L received FDA 510(k) clearance on 2017-10-12, under 510(k) number K170147.

Who is the listed applicant for Lucica Glycated Albumin-L?

The FDA 510(k) record lists Asahi Kasei Pharma Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Lucica Glycated Albumin-L?

The FDA product code for Lucica Glycated Albumin-L is LCP.

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