Xpert vanA
K 號：K243405 · 2024-11-21
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器材摘要
Xpert vanA is the device name listed in this FDA 510(k) record. The listed applicant is Cepheid®. It received FDA 510(k) clearance on 2024-11-21 under 510(k) number K243405. The device is classified under product code NIJ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Xpert vanA?
Xpert vanA is a medical device that received FDA 510(k) clearance on 2024-11-21. The listed applicant is Cepheid®. The 510(k) number is K243405.
When did Xpert vanA receive FDA 510(k) clearance?
Xpert vanA received FDA 510(k) clearance on 2024-11-21, under 510(k) number K243405.
Who is the listed applicant for Xpert vanA?
The FDA 510(k) record lists Cepheid® as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Xpert vanA?
The FDA product code for Xpert vanA is NIJ.
相關臨床試驗
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。
其他以 Cepheid® 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。
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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