凱比立延長病毒傳播檢測儀
K 號：K231027 · 2023-12-21
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決定日期2023-12-21
產品代碼JSM
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
KaiBiLi Extended ViralTrans is the device name listed in this FDA 510(k) record. The listed applicant is Hangzhou Genesis Biodetection & Biocontrol Co., Ltd.. It received FDA 510(k) clearance on 2023-12-21 under 510(k) number K231027. The device is classified under product code JSM. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the KaiBiLi Extended ViralTrans?
KaiBiLi Extended ViralTrans is a medical device that received FDA 510(k) clearance on 2023-12-21. The listed applicant is Hangzhou Genesis Biodetection & Biocontrol Co., Ltd.. The 510(k) number is K231027.
When did KaiBiLi Extended ViralTrans receive FDA 510(k) clearance?
KaiBiLi Extended ViralTrans received FDA 510(k) clearance on 2023-12-21, under 510(k) number K231027.
Who is the listed applicant for KaiBiLi Extended ViralTrans?
The FDA 510(k) record lists Hangzhou Genesis Biodetection & Biocontrol Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for KaiBiLi Extended ViralTrans?
The FDA product code for KaiBiLi Extended ViralTrans is JSM.
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。
相關器械（代碼：JSM）
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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