FDA 510(k)

Nova Allegro HbA1c检测，Nova Allegro分析仪

K号: K221326 · 2024-11-22

决定日期2024-11-22

产品代码LCP

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决定实质等同

器械摘要

Nova Allegro HbA1c 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 2024-11-22 under 510(k) number K221326. The device is classified under product code LCP. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Nova Allegro HbA1c Assay, Nova Allegro Analyzer?

Nova Allegro HbA1c Assay, Nova Allegro Analyzer is a medical device that received FDA 510(k) clearance on 2024-11-22. The listed applicant is Nova Biomedical Corporation. The 510(k) number is K221326.

When did Nova Allegro HbA1c Assay, Nova Allegro Analyzer receive FDA 510(k) clearance?

Nova Allegro HbA1c Assay, Nova Allegro Analyzer received FDA 510(k) clearance on 2024-11-22, under 510(k) number K221326.

Who is the listed applicant for Nova Allegro HbA1c 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 HbA1c Assay, Nova Allegro Analyzer?

The FDA product code for Nova Allegro HbA1c Assay, Nova Allegro Analyzer is LCP.

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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