FDA 510(k)

VIDAS 肾功能检测

K号: K210793 · 2022-07-08

决定日期2022-07-08

产品代码PIG

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决定实质等同

器械摘要

VIDAS NEPHROCHECK is the device name listed in this FDA 510(k) record. The listed applicant is Biomérieux SA. It received FDA 510(k) clearance on 2022-07-08 under 510(k) number K210793. The device is classified under product code PIG. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the VIDAS NEPHROCHECK?

VIDAS NEPHROCHECK is a medical device that received FDA 510(k) clearance on 2022-07-08. The listed applicant is Biomérieux SA. The 510(k) number is K210793.

When did VIDAS NEPHROCHECK receive FDA 510(k) clearance?

VIDAS NEPHROCHECK received FDA 510(k) clearance on 2022-07-08, under 510(k) number K210793.

Who is the listed applicant for VIDAS NEPHROCHECK?

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

What is the FDA product code for VIDAS NEPHROCHECK?

The FDA product code for VIDAS NEPHROCHECK is PIG.

列明Biomérieux SA为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K260447ETEST吉普他汀（GEP）（0.016-256 µg/mL）K200512ETEST普拉茚胺（PLZ）（0.016-256 µg/mL）

官方来源

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