Flowflex® Plus COVID-19 家庭檢測
K 號：K233373 · 2024-04-19
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器材摘要
Flowflex® Plus COVID-19 Home Test is the device name listed in this FDA 510(k) record. The listed applicant is ACON Laboratories, Inc.. It received FDA 510(k) clearance on 2024-04-19 under 510(k) number K233373. The device is classified under product code QYT. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Flowflex® Plus COVID-19 Home Test?
Flowflex® Plus COVID-19 Home Test is a medical device that received FDA 510(k) clearance on 2024-04-19. The listed applicant is ACON Laboratories, Inc.. The 510(k) number is K233373.
When did Flowflex® Plus COVID-19 Home Test receive FDA 510(k) clearance?
Flowflex® Plus COVID-19 Home Test received FDA 510(k) clearance on 2024-04-19, under 510(k) number K233373.
Who is the listed applicant for Flowflex® Plus COVID-19 Home Test?
The FDA 510(k) record lists ACON Laboratories, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Flowflex® Plus COVID-19 Home Test?
The FDA product code for Flowflex® Plus COVID-19 Home Test is QYT.
相關臨床試驗
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其他以 ACON Laboratories, Inc. 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。
相關器械（代碼：QYT）
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
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。
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