免责声明: 本站汇总 FDA、ClinicalTrials.gov、PubMed、SEC EDGAR 等官方公开数据,仅供一般参考,不构成医疗建议、诊断、治疗建议或投资建议。

FDA 510(k)

优米森C1200免疫球蛋白A,优米森C1200免疫球蛋白G,优米森C1200免疫球蛋白M

K号: K193525 · 2020-06-26

决定日期2020-06-26
产品代码CZP
咨询委员会抱歉,您提供的信息不完整,无法进行翻译。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

Yumizen C1200 Immunoglobulin A, Yumizen C1200 Immunoglobulin G, Yumizen C1200 Immunoglobulin M is the device name listed in this FDA 510(k) record. The listed applicant is HORIBA ABX SAS. It received FDA 510(k) clearance on 2020-06-26 under 510(k) number K193525. The device is classified under product code CZP. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Yumizen C1200 Immunoglobulin A, Yumizen C1200 Immunoglobulin G, Yumizen C1200 Immunoglobulin M?

Yumizen C1200 Immunoglobulin A, Yumizen C1200 Immunoglobulin G, Yumizen C1200 Immunoglobulin M is a medical device that received FDA 510(k) clearance on 2020-06-26. The listed applicant is HORIBA ABX SAS. The 510(k) number is K193525.

When did Yumizen C1200 Immunoglobulin A, Yumizen C1200 Immunoglobulin G, Yumizen C1200 Immunoglobulin M receive FDA 510(k) clearance?

Yumizen C1200 Immunoglobulin A, Yumizen C1200 Immunoglobulin G, Yumizen C1200 Immunoglobulin M received FDA 510(k) clearance on 2020-06-26, under 510(k) number K193525.

Who is the listed applicant for Yumizen C1200 Immunoglobulin A, Yumizen C1200 Immunoglobulin G, Yumizen C1200 Immunoglobulin M?

FDA 510(k)记录显示HORIBA ABX SAS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 Yumizen C1200 Immunoglobulin A, Yumizen C1200 Immunoglobulin G, Yumizen C1200 Immunoglobulin M?

The FDA product code for Yumizen C1200 Immunoglobulin A, Yumizen C1200 Immunoglobulin G, Yumizen C1200 Immunoglobulin M is CZP.

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。

列明HORIBA ABX SAS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。

查看所有 10 个设备 →

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。

↑