Dextramer CMV试剂盒
K号: K153538 · 2017-03-02
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申请人Immudex Aps
决定日期2017-03-02
产品代码GKZ
咨询委员会HE
请注意，由于您只提供了“HE”作为输入，我无法提供完整的翻译。请提供完整的描述或文本，以便我能够进行准确的翻译。
决定实质等同
器械摘要
Dextramer CMV Kit is the device name listed in this FDA 510(k) record. The listed applicant is Immudex Aps. It received FDA 510(k) clearance on 2017-03-02 under 510(k) number K153538. The device is classified under product code GKZ. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Dextramer CMV Kit?
Dextramer CMV Kit is a medical device that received FDA 510(k) clearance on 2017-03-02. The listed applicant is Immudex Aps. The 510(k) number is K153538.
When did Dextramer CMV Kit receive FDA 510(k) clearance?
Dextramer CMV Kit received FDA 510(k) clearance on 2017-03-02, under 510(k) number K153538.
Who is the listed applicant for Dextramer CMV Kit?
The FDA 510(k) record lists Immudex Aps as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Dextramer CMV Kit?
The FDA product code for Dextramer CMV Kit is GKZ.
相关临床试验
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相关器械（代码：GKZ）
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。
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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