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FDA 510(k)

DxA 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B12

K号: K190298 · 2019-10-04

申请人Beckman Coulter Biomedical GmbH
决定日期2019-10-04
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

DxA 5000, DxI 800 Access Immunoassay System, Access Ferritin, Access Folate, Access TSH (3rd IS), Access Vitamin B12 is the device name listed in this FDA 510(k) record. The listed applicant is Beckman Coulter Biomedical GmbH. It received FDA 510(k) clearance on 2019-10-04 under 510(k) number K190298. 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 DxA 5000, DxI 800 Access Immunoassay System, Access Ferritin, Access Folate, Access TSH (3rd IS), Access Vitamin B12?

DxA 5000, DxI 800 Access Immunoassay System, Access Ferritin, Access Folate, Access TSH (3rd IS), Access Vitamin B12 is a medical device that received FDA 510(k) clearance on 2019-10-04. The listed applicant is Beckman Coulter Biomedical GmbH. The 510(k) number is K190298.

When did DxA 5000, DxI 800 Access Immunoassay System, Access Ferritin, Access Folate, Access TSH (3rd IS), Access Vitamin B12 receive FDA 510(k) clearance?

DxA 5000, DxI 800 Access Immunoassay System, Access Ferritin, Access Folate, Access TSH (3rd IS), Access Vitamin B12 received FDA 510(k) clearance on 2019-10-04, under 510(k) number K190298.

Who is the listed applicant for DxA 5000, DxI 800 Access Immunoassay System, Access Ferritin, Access Folate, Access TSH (3rd IS), Access Vitamin B12?

The FDA 510(k) record lists Beckman Coulter Biomedical GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DxA 5000, DxI 800 Access Immunoassay System, Access Ferritin, Access Folate, Access TSH (3rd IS), Access Vitamin B12?

The FDA product code for DxA 5000, DxI 800 Access Immunoassay System, Access Ferritin, Access Folate, Access TSH (3rd IS), Access Vitamin B12 is CDD.

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。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

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。

K233541ARCHITECT Active-B12（全转钴胺素）Axis-Shield Diagnostics, Ltd.K223289Access 维生素B12Beckman Coulter, Inc.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 LaboratoriesK160757ADVIA 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

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。

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