FDA 510(k)

iHealth COVID-19 抗原快速检测

K号: K233842 · 2024-05-31

决定日期2024-05-31

产品代码QYT

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器械摘要

iHealth COVID-19 Antigen Rapid Test is the device name listed in this FDA 510(k) record. The listed applicant is Ihealth Labs, Inc.. It received FDA 510(k) clearance on 2024-05-31 under 510(k) number K233842. 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 iHealth COVID-19 Antigen Rapid Test?

iHealth COVID-19 Antigen Rapid Test is a medical device that received FDA 510(k) clearance on 2024-05-31. The listed applicant is Ihealth Labs, Inc.. The 510(k) number is K233842.

When did iHealth COVID-19 Antigen Rapid Test receive FDA 510(k) clearance?

iHealth COVID-19 Antigen Rapid Test received FDA 510(k) clearance on 2024-05-31, under 510(k) number K233842.

Who is the listed applicant for iHealth COVID-19 Antigen Rapid Test?

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

What is the FDA product code for iHealth COVID-19 Antigen Rapid Test?

The FDA product code for iHealth COVID-19 Antigen Rapid Test is QYT.

列明Ihealth Labs, 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。

K251092iHealth 流感A&B/COVID-19 快速测试；iHealth 流感A&B/COVID-19 快速测试专业版 K251085iHealth流感A&B/COVID-19/RSV快速检测；iHealth流感A&B/COVID-19/RSV快速检测专业版 K243146iCare 应用程序

官方来源

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