FDA 510(k)

科博斯 HCV

K号: K252484 · 2025-11-03

决定日期2025-11-03

产品代码MZP

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决定实质等同

器械摘要

cobas HCV is the device name listed in this FDA 510(k) record. The listed applicant is Roche Molecular Systems, Inc.. It received FDA 510(k) clearance on 2025-11-03 under 510(k) number K252484. The device is classified under product code MZP. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the cobas HCV?

cobas HCV is a medical device that received FDA 510(k) clearance on 2025-11-03. The listed applicant is Roche Molecular Systems, Inc.. The 510(k) number is K252484.

When did cobas HCV receive FDA 510(k) clearance?

cobas HCV received FDA 510(k) clearance on 2025-11-03, under 510(k) number K252484.

Who is the listed applicant for cobas HCV?

FDA 510(k)记录中列出罗氏分子系统有限公司为申请人。这本身并不足以确立该设备制造商的身份。

What is the FDA product code for cobas HCV?

The FDA product code for cobas HCV is MZP.

列明Roche Molecular Systems, 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。

K260047cobas Strep A 核酸检测，用于cobas Liat系统（07341911190）；cobas Strep A 质量控制试剂盒（07402678190）K260045cobas® Cdiff 核酸检测，用于 cobas® Liat® 系统（07454945190）；cobas® Cdiff 阳性及阴性对照试剂盒，用于 cobas® Liat® 系统（07454970190）K260021cobas® BV/CV K260917cobas CT/NG 用于 cobas 5800/6800/8800 系统；cobas TV/MG 用于 cobas 5800/6800/8800 系统 K253756cobas liat CT/NG 核酸检测 K253759科博斯利亚特CT/NG/MG核酸检测

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官方来源

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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。