维斯比医疗流感及COVID-19检测
K号: K253971 · 2026-05-27
广告
决定日期2026-05-27
产品代码SIA
咨询委员会抱歉，您提供的内容“MI”不足以进行翻译。请提供完整的医疗设备监管文本，以便我能够进行准确的翻译。
决定实质等同
器械摘要
Visby Medical Flu and COVID-19 Test is the device name listed in this FDA 510(k) record. The listed applicant is Visby Medical, Inc.. It received FDA 510(k) clearance on 2026-05-27 under 510(k) number K253971. The device is classified under product code SIA. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Visby Medical Flu and COVID-19 Test?
Visby Medical Flu and COVID-19 Test is a medical device that received FDA 510(k) clearance on 2026-05-27. The listed applicant is Visby Medical, Inc.. The 510(k) number is K253971.
When did Visby Medical Flu and COVID-19 Test receive FDA 510(k) clearance?
Visby Medical Flu and COVID-19 Test received FDA 510(k) clearance on 2026-05-27, under 510(k) number K253971.
Who is the listed applicant for Visby Medical Flu and COVID-19 Test?
The FDA 510(k) record lists Visby Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Visby Medical Flu and COVID-19 Test?
The FDA product code for Visby Medical Flu and COVID-19 Test is SIA.
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Visby Medical, Inc.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