COVID-19 分子檢測儀
K 號：K232643 · 2023-11-28
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器材摘要
Cue COVID-19 Molecular Test is the device name listed in this FDA 510(k) record. The listed applicant is Cue Health, Inc.. It received FDA 510(k) clearance on 2023-11-28 under 510(k) number K232643. The device is classified under product code QWB. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Cue COVID-19 Molecular Test?
Cue COVID-19 Molecular Test is a medical device that received FDA 510(k) clearance on 2023-11-28. The listed applicant is Cue Health, Inc.. The 510(k) number is K232643.
When did Cue COVID-19 Molecular Test receive FDA 510(k) clearance?
Cue COVID-19 Molecular Test received FDA 510(k) clearance on 2023-11-28, under 510(k) number K232643.
Who is the listed applicant for Cue COVID-19 Molecular Test?
The FDA 510(k) record lists Cue Health, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Cue COVID-19 Molecular Test?
The FDA product code for Cue COVID-19 Molecular Test is QWB.
相關臨床試驗
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相關器械（代碼：QWB）
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。
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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