cobas CT/NG 用于 cobas 6800/8800 系统
K号: K173887 · 2018-03-21
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决定日期2018-03-21
产品代码LSL
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决定实质等同
器械摘要
cobas CT/NG for use on cobas 6800/8800 systems 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 2018-03-21 under 510(k) number K173887. The device is classified under product code LSL. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the cobas CT/NG for use on cobas 6800/8800 systems?
cobas CT/NG for use on cobas 6800/8800 systems is a medical device that received FDA 510(k) clearance on 2018-03-21. The listed applicant is Roche Molecular Systems, Inc.. The 510(k) number is K173887.
When did cobas CT/NG for use on cobas 6800/8800 systems receive FDA 510(k) clearance?
cobas CT/NG for use on cobas 6800/8800 systems received FDA 510(k) clearance on 2018-03-21, under 510(k) number K173887.
Who is the listed applicant for cobas CT/NG for use on cobas 6800/8800 systems?
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 CT/NG for use on cobas 6800/8800 systems?
The FDA product code for cobas CT/NG for use on cobas 6800/8800 systems is LSL.
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。
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）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）K260021cobas® BV/CVK260917cobas 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
相关器械（代码：LSL）
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。
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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