FDA 510(k)

Access 总βhCG (5th IS)

K号: K221990 · 2022-12-27

决定日期2022-12-27

产品代码DHA

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

Access Total ßhCG (5th IS) is the device name listed in this FDA 510(k) record. The listed applicant is Beckman Coulter, Inc.. It received FDA 510(k) clearance on 2022-12-27 under 510(k) number K221990. The device is classified under product code DHA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Access Total ßhCG (5th IS)?

Access Total ßhCG (5th IS) is a medical device that received FDA 510(k) clearance on 2022-12-27. The listed applicant is Beckman Coulter, Inc.. The 510(k) number is K221990.

When did Access Total ßhCG (5th IS) receive FDA 510(k) clearance?

Access Total ßhCG (5th IS) received FDA 510(k) clearance on 2022-12-27, under 510(k) number K221990.

Who is the listed applicant for Access Total ßhCG (5th IS)?

FDA 510(k)记录中列出Beckman Coulter, Inc.为申请人。这本身并不能确立该设备制造商的身份。

What is the FDA product code for Access Total ßhCG (5th IS)?

The FDA product code for Access Total ßhCG (5th IS) is DHA.

列明Beckman Coulter, Inc.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。

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相关器械（代码：DHA）

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。

K233581VITROS 免疫诊断产品总β-hCG II 试剂套装Ortho Clinical Diagnostics K223690iFlash-HCG; 化学发光免疫分析仪（型号：iFlash 3000-C）Shenzhen Yhlo Biotech Co., Ltd.K230937Alinity i 总β-hCG试剂套件，GLP系统追踪Abbott Laboratories K230790Alinity i 总β-hCG试剂套件，Alinity c 葡萄糖试剂套件，Alinity c ICT样本稀释液，Alinity ci系列Abbott Laboratories K212221Diazyme DZ-Lite iFlash 总β-hCG 测定，Diazyme DZ-Lite iFlash 1800 化学发光免疫测定分析仪Diazyme Laboratories, Inc.K203227Elecsys HCG STATRoche Diagnostics

官方来源

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