ACTIVE® 自由睾酮放射免疫测定
K号: K191350 · 2019-12-20
广告
决定日期2019-12-20
产品代码CDZ
咨询委员会CH
请注意，您提供的文本“CH”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
ACTIVE® Free Testosterone RIA is the device name listed in this FDA 510(k) record. The listed applicant is Immunotech S.R.O.. It received FDA 510(k) clearance on 2019-12-20 under 510(k) number K191350. The device is classified under product code CDZ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the ACTIVE® Free Testosterone RIA?
ACTIVE® Free Testosterone RIA is a medical device that received FDA 510(k) clearance on 2019-12-20. The listed applicant is Immunotech S.R.O.. The 510(k) number is K191350.
When did ACTIVE® Free Testosterone RIA receive FDA 510(k) clearance?
ACTIVE® Free Testosterone RIA received FDA 510(k) clearance on 2019-12-20, under 510(k) number K191350.
Who is the listed applicant for ACTIVE® Free Testosterone RIA?
The FDA 510(k) record lists Immunotech S.R.O. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for ACTIVE® Free Testosterone RIA?
The FDA product code for ACTIVE® Free Testosterone RIA is CDZ.
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：CDZ）
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