Access BNP II
K号: K252169 · 2026-03-24
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决定日期2026-03-24
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
Access BNP II is the device name listed in this FDA 510(k) record. The listed applicant is Beckman Coulter, Inc.. It received FDA 510(k) clearance on 2026-03-24 under 510(k) number K252169. 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 Access BNP II?
Access BNP II is a medical device that received FDA 510(k) clearance on 2026-03-24. The listed applicant is Beckman Coulter, Inc.. The 510(k) number is K252169.
When did Access BNP II receive FDA 510(k) clearance?
Access BNP II received FDA 510(k) clearance on 2026-03-24, under 510(k) number K252169.
Who is the listed applicant for Access BNP II?
FDA 510(k)记录中列出Beckman Coulter, Inc.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 Access BNP II?
The FDA product code for Access BNP II 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Beckman Coulter, 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：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.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.K223637Elecsys proBNP II，Elecsys proBNP II STATRoche Diagnostics
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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