他克莫司测定试剂盒
K号: K203833 · 2023-01-27
广告
决定日期2023-01-27
产品代码MLM
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
Tacrolimus Assay Kit is the device name listed in this FDA 510(k) record. The listed applicant is Shanghai Genext Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2023-01-27 under 510(k) number K203833. The device is classified under product code MLM. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Tacrolimus Assay Kit?
Tacrolimus Assay Kit is a medical device that received FDA 510(k) clearance on 2023-01-27. The listed applicant is Shanghai Genext Medical Technology Co., Ltd.. The 510(k) number is K203833.
When did Tacrolimus Assay Kit receive FDA 510(k) clearance?
Tacrolimus Assay Kit received FDA 510(k) clearance on 2023-01-27, under 510(k) number K203833.
Who is the listed applicant for Tacrolimus Assay Kit?
The FDA 510(k) record lists Shanghai Genext Medical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Tacrolimus Assay Kit?
The FDA product code for Tacrolimus Assay Kit is MLM.
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：MLM）
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