FDA 510(k)

CorDx Tyfast COVID-19 Ag 快速检测试剂; CorDx COVID-19 Ag 检测

K号: K240728 · 2024-06-21

决定日期2024-06-21

产品代码QYT

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决定实质等同

器械摘要

CorDx Tyfast COVID-19 Ag Rapid Test; CorDx COVID-19 Ag Test is the device name listed in this FDA 510(k) record. The listed applicant is CorDx, Inc.. It received FDA 510(k) clearance on 2024-06-21 under 510(k) number K240728. 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 CorDx Tyfast COVID-19 Ag Rapid Test; CorDx COVID-19 Ag Test?

CorDx Tyfast COVID-19 Ag Rapid Test; CorDx COVID-19 Ag Test is a medical device that received FDA 510(k) clearance on 2024-06-21. The listed applicant is CorDx, Inc.. The 510(k) number is K240728.

When did CorDx Tyfast COVID-19 Ag Rapid Test; CorDx COVID-19 Ag Test receive FDA 510(k) clearance?

CorDx Tyfast COVID-19 Ag Rapid Test; CorDx COVID-19 Ag Test received FDA 510(k) clearance on 2024-06-21, under 510(k) number K240728.

Who is the listed applicant for CorDx Tyfast COVID-19 Ag Rapid Test; CorDx COVID-19 Ag Test?

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

What is the FDA product code for CorDx Tyfast COVID-19 Ag Rapid Test; CorDx COVID-19 Ag Test?

The FDA product code for CorDx Tyfast COVID-19 Ag Rapid Test; CorDx COVID-19 Ag Test is QYT.

列明CorDx, Inc.为申报人的其他记录

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K253882CorDx Tyfast COVID-19 Ag 快速检测试剂

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