FDA 510(k)

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

K 號：K243256 · 2025-01-16

決定日期2025-01-16

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™ COVID-19 / Influenza A&B Home Test; WELLlife™ COVID-19 / Influenza A&B AntigenTest 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 2025-01-16 under 510(k) number K243256. 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™ COVID-19 / Influenza A&B Home Test; WELLlife™ COVID-19 / Influenza A&B AntigenTest?

WELLlife™ COVID-19 / Influenza A&B Home Test; WELLlife™ COVID-19 / Influenza A&B AntigenTest is a medical device that received FDA 510(k) clearance on 2025-01-16. The listed applicant is Wondfo USA Co, Ltd.. The 510(k) number is K243256.

When did WELLlife™ COVID-19 / Influenza A&B Home Test; WELLlife™ COVID-19 / Influenza A&B AntigenTest receive FDA 510(k) clearance?

WELLlife™ COVID-19 / Influenza A&B Home Test; WELLlife™ COVID-19 / Influenza A&B AntigenTest received FDA 510(k) clearance on 2025-01-16, under 510(k) number K243256.

Who is the listed applicant for WELLlife™ COVID-19 / Influenza A&B Home Test; WELLlife™ COVID-19 / Influenza A&B AntigenTest?

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™ COVID-19 / Influenza A&B Home Test; WELLlife™ COVID-19 / Influenza A&B AntigenTest?

The FDA product code for WELLlife™ COVID-19 / Influenza A&B Home Test; WELLlife™ COVID-19 / Influenza A&B AntigenTest 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。

K251563WELLlife 流感A&B家庭檢測；WELLlife 流感A&B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。

K261212Flowflex Plus RSV + 流行性感冒A/B + COVID 快速檢測ACON Laboratories, Inc.K251085iHealth 流感A&B/COVID-19/RSV 快速檢測；iHealth 流感A&B/COVID-19/RSV 快速檢測 ProIhealth Labs, Inc.K251092iHealth流感A&B/COVID-19快速檢測; iHealth流感A&B/COVID-19快速檢測ProIhealth Labs, Inc.K251538Status™ COVID-19/流感A&BPrinceton BioMeditech Corp.K251749Flowflex Plus RSV + 流行性感冒A/B + COVID家庭檢測ACON Laboratories, Inc.K251604CareSuperb COVID-19/流感A&B抗原組合居家檢測Access Bio, Inc.

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。