含三羟甲基氨基甲烷稀释剂的低钾右旋糖酐溶液
K号: K153384 · 2016-02-19
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决定日期2016-02-19
产品代码KDN
咨询委员会GU
请注意，由于您只提供了“GU”这个词，我无法提供完整的翻译。如果您能提供完整的句子或段落，我将能够为您提供准确的翻译。
决定实质等同
器械摘要
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.
常见问题
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.
相关临床试验
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
相关器械（代码：KDN）
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
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官方来源
在 FDA 数据库中查看 →数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。
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