binx io CT/NG 检测和 binx io CT/NG 系统
K号: K200533 · 2020-04-27
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决定日期2020-04-27
产品代码QEP
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决定实质等同
器械摘要
binx io CT/NG Assay and binx io CT/NG System is the device name listed in this FDA 510(k) record. The listed applicant is Binx Health, Inc.. It received FDA 510(k) clearance on 2020-04-27 under 510(k) number K200533. The device is classified under product code QEP. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the binx io CT/NG Assay and binx io CT/NG System?
binx io CT/NG Assay and binx io CT/NG System is a medical device that received FDA 510(k) clearance on 2020-04-27. The listed applicant is Binx Health, Inc.. The 510(k) number is K200533.
When did binx io CT/NG Assay and binx io CT/NG System receive FDA 510(k) clearance?
binx io CT/NG Assay and binx io CT/NG System received FDA 510(k) clearance on 2020-04-27, under 510(k) number K200533.
Who is the listed applicant for binx io CT/NG Assay and binx io CT/NG System?
The FDA 510(k) record lists Binx Health, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for binx io CT/NG Assay and binx io CT/NG System?
The FDA product code for binx io CT/NG Assay and binx io CT/NG System is QEP.
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Binx Health, 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。
相关器械（代码：QEP）
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。
K260917cobas CT/NG 用于 cobas 5800/6800/8800 系统；cobas TV/MG 用于 cobas 5800/6800/8800 系统Roche Molecular Systems, Inc.K253759科博斯利亚特CT/NG/MG核酸检测Roche Molecular Systems, Inc.K253756cobas liat CT/NG 核酸检测Roche Molecular Systems, Inc.K251501维斯比医疗男性性健康检测Visby Medical, Inc.K243343BD CTGCTV2Bd Integrated Diagnostic Solutions/Becton,K240217cobas® liat CT/NG 核酸检测Roche Molecular Systems, Inc.
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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