他克莫司測試套件
K 號：K203833 · 2023-01-27
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器材摘要
Tacrolimus Assay Kit is the device name listed in this FDA 510(k) record. The listed applicant is Shanghai Genext Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2023-01-27 under 510(k) number K203833. The device is classified under product code MLM. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Tacrolimus Assay Kit?
Tacrolimus Assay Kit is a medical device that received FDA 510(k) clearance on 2023-01-27. The listed applicant is Shanghai Genext Medical Technology Co., Ltd.. The 510(k) number is K203833.
When did Tacrolimus Assay Kit receive FDA 510(k) clearance?
Tacrolimus Assay Kit received FDA 510(k) clearance on 2023-01-27, under 510(k) number K203833.
Who is the listed applicant for Tacrolimus Assay Kit?
The FDA 510(k) record lists Shanghai Genext Medical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Tacrolimus Assay Kit?
The FDA product code for Tacrolimus Assay Kit is MLM.
相關臨床試驗
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相關器械（代碼：MLM）
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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