FDA 510(k)

ケアスーパー COVID-19/インフルエンザA&B 抗原コンボホームテスト

K番号: K251604 · 2025-08-22

決定日2025-08-22

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

CareSuperb COVID-19/Flu A&B Antigen Combo Home Test is the device name listed in this FDA 510(k) record. The listed applicant is Access Bio, Inc.. It received FDA 510(k) clearance on 2025-08-22 under 510(k) number K251604. 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 CareSuperb COVID-19/Flu A&B Antigen Combo Home Test?

CareSuperb COVID-19/Flu A&B Antigen Combo Home Test is a medical device that received FDA 510(k) clearance on 2025-08-22. The listed applicant is Access Bio, Inc.. The 510(k) number is K251604.

When did CareSuperb COVID-19/Flu A&B Antigen Combo Home Test receive FDA 510(k) clearance?

CareSuperb COVID-19/Flu A&B Antigen Combo Home Test received FDA 510(k) clearance on 2025-08-22, under 510(k) number K251604.

Who is the listed applicant for CareSuperb COVID-19/Flu A&B Antigen Combo Home Test?

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

What is the FDA product code for CareSuperb COVID-19/Flu A&B Antigen Combo Home Test?

The FDA product code for CareSuperb COVID-19/Flu A&B Antigen Combo Home Test is SCA.

申請者としてAccess Bio, Inc.を記載するその他の記録

K241915ケアスーパー™ COVID-19 抗原在宅検査 K191514ケアスタートインフルエンザA&Bプラス

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