ISE電極
K 號：K230890 · 2023-09-08
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器材摘要
ISE Electrodes is the device name listed in this FDA 510(k) record. The listed applicant is Randox Laboratories, Ltd.. It received FDA 510(k) clearance on 2023-09-08 under 510(k) number K230890. The device is classified under product code CEM. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the ISE Electrodes?
ISE Electrodes is a medical device that received FDA 510(k) clearance on 2023-09-08. The listed applicant is Randox Laboratories, Ltd.. The 510(k) number is K230890.
When did ISE Electrodes receive FDA 510(k) clearance?
ISE Electrodes received FDA 510(k) clearance on 2023-09-08, under 510(k) number K230890.
Who is the listed applicant for ISE Electrodes?
The FDA 510(k) record lists Randox Laboratories, Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for ISE Electrodes?
The FDA product code for ISE Electrodes is CEM.
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其他以 Randox Laboratories, 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。
相關器械（代碼：CEM）
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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