Curian® Shiga Toxin
K号: K222829 · 2023-04-17
广告
决定日期2023-04-17
产品代码GMZ
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
Curian® Shiga Toxin is the device name listed in this FDA 510(k) record. The listed applicant is Meridian Bioscience, Inc.. It received FDA 510(k) clearance on 2023-04-17 under 510(k) number K222829. The device is classified under product code GMZ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Curian® Shiga Toxin?
Curian® Shiga Toxin is a medical device that received FDA 510(k) clearance on 2023-04-17. The listed applicant is Meridian Bioscience, Inc.. The 510(k) number is K222829.
When did Curian® Shiga Toxin receive FDA 510(k) clearance?
Curian® Shiga Toxin received FDA 510(k) clearance on 2023-04-17, under 510(k) number K222829.
Who is the listed applicant for Curian® Shiga Toxin?
The FDA 510(k) record lists Meridian Bioscience, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Curian® Shiga Toxin?
The FDA product code for Curian® Shiga Toxin is GMZ.
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Meridian Bioscience, 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