FDA 510(k)

Nova Allegro UACR检测，Nova Allegro分析仪

K号: K252206 · 2026-01-09

决定日期2026-01-09

产品代码CGX

咨询委员会CH 请注意，您提供的文本“CH”不足以进行翻译。请提供完整的医疗设备监管文本，以便我能够进行准确的翻译。

决定实质等同

器械摘要

Nova Allegro UACR Assay, Nova Allegro Analyzer is the device name listed in this FDA 510(k) record. The listed applicant is Nova Biomedical Corporation. It received FDA 510(k) clearance on 2026-01-09 under 510(k) number K252206. The device is classified under product code CGX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Nova Allegro UACR Assay, Nova Allegro Analyzer?

Nova Allegro UACR Assay, Nova Allegro Analyzer is a medical device that received FDA 510(k) clearance on 2026-01-09. The listed applicant is Nova Biomedical Corporation. The 510(k) number is K252206.

When did Nova Allegro UACR Assay, Nova Allegro Analyzer receive FDA 510(k) clearance?

Nova Allegro UACR Assay, Nova Allegro Analyzer received FDA 510(k) clearance on 2026-01-09, under 510(k) number K252206.

Who is the listed applicant for Nova Allegro UACR Assay, Nova Allegro Analyzer?

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

What is the FDA product code for Nova Allegro UACR Assay, Nova Allegro Analyzer?

The FDA product code for Nova Allegro UACR Assay, Nova Allegro Analyzer is CGX.

列明Nova Biomedical Corporation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。

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