STA® - Liatest® D-Di
K号: K162227 · 2016-12-10
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决定日期2016-12-10
产品代码DAP
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
STA® - Liatest® D-Di is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostica Stago. It received FDA 510(k) clearance on 2016-12-10 under 510(k) number K162227. The device is classified under product code DAP. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the STA® - Liatest® D-Di?
STA® - Liatest® D-Di is a medical device that received FDA 510(k) clearance on 2016-12-10. The listed applicant is Diagnostica Stago. The 510(k) number is K162227.
When did STA® - Liatest® D-Di receive FDA 510(k) clearance?
STA® - Liatest® D-Di received FDA 510(k) clearance on 2016-12-10, under 510(k) number K162227.
Who is the listed applicant for STA® - Liatest® D-Di?
The FDA 510(k) record lists Diagnostica Stago as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for STA® - Liatest® D-Di?
The FDA product code for STA® - Liatest® D-Di is DAP.
相关临床试验
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相关器械（代码：DAP）
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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