FDA 510(k)

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

K番号: K251085 · 2025-12-12

決定日2025-12-12

製品コードSCA

諮問委員会以下は、提供された医療機器規制テキストの日本語訳です。 --- MI --- URLや識別子などは原文のままです。

決定大幅同等

医療機器の概要

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.

よくある質問

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.

申請者としてIhealth Labs, Inc.を記載するその他の記録

K251092iHealth Flu A&B/COVID-19迅速検査；iHealth Flu A&B/COVID-19迅速検査プロ K243146iCare APP K233842iHealth COVID-19 Antigen Rapid Test

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