FDA 510(k)

WELLlife 流感A&B家庭檢測；WELLlife 流感A&B檢測

K 號：K251563 · 2025-08-20

決定日期2025-08-20

產品代碼SCA

諮詢委員會MI (請提供完整的描述文本，以便進行翻譯。)

決定相當於

器材摘要

WELLlife Flu A&B Home Test; WELLlife Influenza A&B Test is the device name listed in this FDA 510(k) record. The listed applicant is Wondfo USA Co, Ltd.. It received FDA 510(k) clearance on 2025-08-20 under 510(k) number K251563. The device is classified under product code SCA. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the WELLlife Flu A&B Home Test; WELLlife Influenza A&B Test?

WELLlife Flu A&B Home Test; WELLlife Influenza A&B Test is a medical device that received FDA 510(k) clearance on 2025-08-20. The listed applicant is Wondfo USA Co, Ltd.. The 510(k) number is K251563.

When did WELLlife Flu A&B Home Test; WELLlife Influenza A&B Test receive FDA 510(k) clearance?

WELLlife Flu A&B Home Test; WELLlife Influenza A&B Test received FDA 510(k) clearance on 2025-08-20, under 510(k) number K251563.

Who is the listed applicant for WELLlife Flu A&B Home Test; WELLlife Influenza A&B Test?

The FDA 510(k) record lists Wondfo USA Co, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for WELLlife Flu A&B Home Test; WELLlife Influenza A&B Test?

The FDA product code for WELLlife Flu A&B Home Test; WELLlife Influenza A&B Test is SCA.

其他以 Wondfo USA Co, Ltd. 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K243256WELLlife™ COVID-19 / 流感A&B 家庭檢測；WELLlife™ COVID-19 / 流感A&B 抗原檢測

相關器械（代碼：SCA）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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官方來源

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