FDA 510(k)

GenaCheck COVID-19 快速自我检测

K号: K251753 · 2025-09-05

决定日期2025-09-05

产品代码QYT

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决定实质等同

器械摘要

GenaCheck COVID-19 Rapid Self-Test is the device name listed in this FDA 510(k) record. The listed applicant is Genabio Diagnostics, Inc.. It received FDA 510(k) clearance on 2025-09-05 under 510(k) number K251753. The device is classified under product code QYT. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the GenaCheck COVID-19 Rapid Self-Test?

GenaCheck COVID-19 Rapid Self-Test is a medical device that received FDA 510(k) clearance on 2025-09-05. The listed applicant is Genabio Diagnostics, Inc.. The 510(k) number is K251753.

When did GenaCheck COVID-19 Rapid Self-Test receive FDA 510(k) clearance?

GenaCheck COVID-19 Rapid Self-Test received FDA 510(k) clearance on 2025-09-05, under 510(k) number K251753.

Who is the listed applicant for GenaCheck COVID-19 Rapid Self-Test?

The FDA 510(k) record lists Genabio Diagnostics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GenaCheck COVID-19 Rapid Self-Test?

The FDA product code for GenaCheck COVID-19 Rapid Self-Test is QYT.

列明Genabio Diagnostics, Inc.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。

K240545GenaCheck® 氮化物粉末免费检查手套，用于化疗药物和芬太尼柠檬酸盐（XS/S/M/L/XL）测试

官方来源

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