Elecsys proBNP II，Elecsys proBNP II STAT
K号: K223637 · 2023-07-21
广告
决定日期2023-07-21
产品代码NBC
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
Elecsys proBNP II, Elecsys proBNP II STAT is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostics. It received FDA 510(k) clearance on 2023-07-21 under 510(k) number K223637. The device is classified under product code NBC. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Elecsys proBNP II, Elecsys proBNP II STAT?
Elecsys proBNP II, Elecsys proBNP II STAT is a medical device that received FDA 510(k) clearance on 2023-07-21. The listed applicant is Roche Diagnostics. The 510(k) number is K223637.
When did Elecsys proBNP II, Elecsys proBNP II STAT receive FDA 510(k) clearance?
Elecsys proBNP II, Elecsys proBNP II STAT received FDA 510(k) clearance on 2023-07-21, under 510(k) number K223637.
Who is the listed applicant for Elecsys proBNP II, Elecsys proBNP II STAT?
FDA 510(k)记录显示罗氏诊断公司为申请人。这本身并不能确立该设备的制造商。
What is the FDA product code for Elecsys proBNP II, Elecsys proBNP II STAT?
The FDA product code for Elecsys proBNP II, Elecsys proBNP II STAT is NBC.
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 Diagnostics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：NBC）
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。
K262109Access NT-proBNPBeckman Coulter, Inc.K252169Access BNP IIBeckman Coulter, Inc.K253539Alere NT-proBNP for Alinity iAxis-Shield Diagnostics, Ltd.K241176Alere NT-proBNP for Alinity i试剂套装Axis-Shield Diagnostics, Ltd.K232164Access NT-proBNPBeckman Coulter, Inc.K220265ADVIA Centaur® NT-proBNPII (PBNPII)Siemens Healthcare Diagnostics, 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。
广告