Xpert vanA
K号: K243405 · 2024-11-21
广告
器械摘要
Xpert vanA is the device name listed in this FDA 510(k) record. The listed applicant is Cepheid®. It received FDA 510(k) clearance on 2024-11-21 under 510(k) number K243405. The device is classified under product code NIJ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Xpert vanA?
Xpert vanA is a medical device that received FDA 510(k) clearance on 2024-11-21. The listed applicant is Cepheid®. The 510(k) number is K243405.
When did Xpert vanA receive FDA 510(k) clearance?
Xpert vanA received FDA 510(k) clearance on 2024-11-21, under 510(k) number K243405.
Who is the listed applicant for Xpert vanA?
The FDA 510(k) record lists Cepheid® as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Xpert vanA?
The FDA product code for Xpert vanA is NIJ.
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。
列明Cepheid®为申报人的其他记录
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。
广告