FDA 510(k)

IDS皮质醇

K号: K202136 · 2021-04-13

决定日期2021-04-13

产品代码CGR

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决定实质等同

器械摘要

IDS Cortisol is the device name listed in this FDA 510(k) record. The listed applicant is Immunodiagnostic Systems , Ltd.. It received FDA 510(k) clearance on 2021-04-13 under 510(k) number K202136. The device is classified under product code CGR. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the IDS Cortisol?

IDS Cortisol is a medical device that received FDA 510(k) clearance on 2021-04-13. The listed applicant is Immunodiagnostic Systems , Ltd.. The 510(k) number is K202136.

When did IDS Cortisol receive FDA 510(k) clearance?

IDS Cortisol received FDA 510(k) clearance on 2021-04-13, under 510(k) number K202136.

Who is the listed applicant for IDS Cortisol?

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

What is the FDA product code for IDS Cortisol?

The FDA product code for IDS Cortisol is CGR.

列明Immunodiagnostic Systems , Ltd.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。

K200475IDS-iSYS 骨酸BAP K190121IDS SHBG K161158IDS-iSYS 完整 PTHN K161831IDS-iSYS 25VitDs，IDS-iSYS 25VitDs 控制套件 K161082IDS-iSYS 17-OH 孕酮控制套件，IDS-iSYS 17-OH 孕酮校准验证器

官方来源

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