低鈉葡聚糖溶液，含Tris稀釋劑
K 號：K153384 · 2016-02-19
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器材摘要
Low Potassium Dextran Solution with Tris Diluent is the device name listed in this FDA 510(k) record. The listed applicant is United Therapeutics Corporation. It received FDA 510(k) clearance on 2016-02-19 under 510(k) number K153384. The device is classified under product code KDN. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Low Potassium Dextran Solution with Tris Diluent?
Low Potassium Dextran Solution with Tris Diluent is a medical device that received FDA 510(k) clearance on 2016-02-19. The listed applicant is United Therapeutics Corporation. The 510(k) number is K153384.
When did Low Potassium Dextran Solution with Tris Diluent receive FDA 510(k) clearance?
Low Potassium Dextran Solution with Tris Diluent received FDA 510(k) clearance on 2016-02-19, under 510(k) number K153384.
Who is the listed applicant for Low Potassium Dextran Solution with Tris Diluent?
The FDA 510(k) record lists United Therapeutics Corporation as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Low Potassium Dextran Solution with Tris Diluent?
The FDA product code for Low Potassium Dextran Solution with Tris Diluent is KDN.
相關臨床試驗
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相關器械（代碼：KDN）
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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