FDA 510(k)

iHealth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

K号: K251085 · 2025-12-12

决定日期2025-12-12

产品代码SCA

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决定实质等同

器械摘要

iHealth Flu A&B/COVID-19/RSV Rapid Test; iHealth Flu A&B/COVID-19/RSV Rapid Test Pro 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 2025-12-12 under 510(k) number K251085. The device is classified under product code SCA. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the iHealth Flu A&B/COVID-19/RSV Rapid Test; iHealth Flu A&B/COVID-19/RSV Rapid Test Pro?

iHealth Flu A&B/COVID-19/RSV Rapid Test; iHealth Flu A&B/COVID-19/RSV Rapid Test Pro is a medical device that received FDA 510(k) clearance on 2025-12-12. The listed applicant is Ihealth Labs, Inc.. The 510(k) number is K251085.

When did iHealth Flu A&B/COVID-19/RSV Rapid Test; iHealth Flu A&B/COVID-19/RSV Rapid Test Pro receive FDA 510(k) clearance?

iHealth Flu A&B/COVID-19/RSV Rapid Test; iHealth Flu A&B/COVID-19/RSV Rapid Test Pro received FDA 510(k) clearance on 2025-12-12, under 510(k) number K251085.

Who is the listed applicant for iHealth Flu A&B/COVID-19/RSV Rapid Test; iHealth Flu A&B/COVID-19/RSV Rapid Test Pro?

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 Flu A&B/COVID-19/RSV Rapid Test; iHealth Flu A&B/COVID-19/RSV Rapid Test Pro?

The FDA product code for iHealth Flu A&B/COVID-19/RSV Rapid Test; iHealth Flu A&B/COVID-19/RSV Rapid Test Pro is SCA.

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 K243146iCare 应用程序 K233842iHealth COVID-19 抗原快速检测

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