ST AIA-PACK BNP 测定
K号: K211199 · 2021-11-08
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决定日期2021-11-08
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
ST AIA-PACK BNP Assay is the device name listed in this FDA 510(k) record. The listed applicant is Tosoh Bioscience, Inc.. It received FDA 510(k) clearance on 2021-11-08 under 510(k) number K211199. 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 ST AIA-PACK BNP Assay?
ST AIA-PACK BNP Assay is a medical device that received FDA 510(k) clearance on 2021-11-08. The listed applicant is Tosoh Bioscience, Inc.. The 510(k) number is K211199.
When did ST AIA-PACK BNP Assay receive FDA 510(k) clearance?
ST AIA-PACK BNP Assay received FDA 510(k) clearance on 2021-11-08, under 510(k) number K211199.
Who is the listed applicant for ST AIA-PACK BNP Assay?
The FDA 510(k) record lists Tosoh Bioscience, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for ST AIA-PACK BNP Assay?
The FDA product code for ST AIA-PACK BNP Assay 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Tosoh Bioscience, 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.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。
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