FDA 510(k)

IDS ACTH II

K号: K223867 · 2023-08-18

决定日期2023-08-18

产品代码CKG

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

IDS ACTH II is the device name listed in this FDA 510(k) record. The listed applicant is Immunodiagnostic Systems Limited. It received FDA 510(k) clearance on 2023-08-18 under 510(k) number K223867. The device is classified under product code CKG. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the IDS ACTH II?

IDS ACTH II is a medical device that received FDA 510(k) clearance on 2023-08-18. The listed applicant is Immunodiagnostic Systems Limited. The 510(k) number is K223867.

When did IDS ACTH II receive FDA 510(k) clearance?

IDS ACTH II received FDA 510(k) clearance on 2023-08-18, under 510(k) number K223867.

Who is the listed applicant for IDS ACTH II?

The FDA 510(k) record lists Immunodiagnostic Systems Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IDS ACTH II?

The FDA product code for IDS ACTH II is CKG.

列明Immunodiagnostic Systems Limited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。

K252728IDS-iSYS 总睾酮 K240865IDS-iSYS 自由睾酮

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。