FDA 510(k)

ARCHITECT Active-B12（全转钴胺素）

K号: K233541 · 2024-07-31

决定日期2024-07-31

产品代码CDD

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

ARCHITECT Active-B12 (Holotranscobalamin) is the device name listed in this FDA 510(k) record. The listed applicant is Axis-Shield Diagnostics, Ltd.. It received FDA 510(k) clearance on 2024-07-31 under 510(k) number K233541. The device is classified under product code CDD. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the ARCHITECT Active-B12 (Holotranscobalamin)?

ARCHITECT Active-B12 (Holotranscobalamin) is a medical device that received FDA 510(k) clearance on 2024-07-31. The listed applicant is Axis-Shield Diagnostics, Ltd.. The 510(k) number is K233541.

When did ARCHITECT Active-B12 (Holotranscobalamin) receive FDA 510(k) clearance?

ARCHITECT Active-B12 (Holotranscobalamin) received FDA 510(k) clearance on 2024-07-31, under 510(k) number K233541.

Who is the listed applicant for ARCHITECT Active-B12 (Holotranscobalamin)?

The FDA 510(k) record lists Axis-Shield Diagnostics, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ARCHITECT Active-B12 (Holotranscobalamin)?

The FDA product code for ARCHITECT Active-B12 (Holotranscobalamin) is CDD.

列明Axis-Shield Diagnostics, 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。

K253539Alere NT-proBNP for Alinity i K241176Alere NT-proBNP for Alinity i试剂套装 K172133ADVIA Centaur Active-B12 (全反式钴胺素) (AB12) 测定

相关器械（代码：CDD）

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。

K223289Access 维生素B12Beckman Coulter, Inc.K190298DxA 5000，DxI 800免疫测定系统，Access铁蛋白，Access叶酸，Access促甲状腺激素（第3个国际标准），Access维生素B12Beckman Coulter Biomedical GmbH K192064LIAISON 维生素B12DiaSorin, Inc.K172133ADVIA Centaur Active-B12 (全反式钴胺素) (AB12) 测定Axis-Shield Diagnostics, Ltd.K161721Diazyme 维生素B12测定，Diazyme 维生素B12校准器套装，Diazyme 维生素B12控制套装Diazyme Laboratories K160757ADVIA Centaur Active-B12 (全反式钴胺素)(AB12) 测定，ADVIA Centaur Active-B12(AB12) 质量控制，以及ADVIA Centaur Active-B12 (AB12) 主曲线材料（MCM）Axis-Shield Diagnostics Limited

官方来源

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