AXINON® LDL-p 测试系统
K号: K210801 · 2023-07-19
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申请人Numares AG
决定日期2023-07-19
产品代码MRR
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
AXINON® LDL-p Test System is the device name listed in this FDA 510(k) record. The listed applicant is Numares AG. It received FDA 510(k) clearance on 2023-07-19 under 510(k) number K210801. The device is classified under product code MRR. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the AXINON® LDL-p Test System?
AXINON® LDL-p Test System is a medical device that received FDA 510(k) clearance on 2023-07-19. The listed applicant is Numares AG. The 510(k) number is K210801.
When did AXINON® LDL-p Test System receive FDA 510(k) clearance?
AXINON® LDL-p Test System received FDA 510(k) clearance on 2023-07-19, under 510(k) number K210801.
Who is the listed applicant for AXINON® LDL-p Test System?
The FDA 510(k) record lists Numares AG as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for AXINON® LDL-p Test System?
The FDA product code for AXINON® LDL-p Test System is MRR.
相关临床试验
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相关器械（代码：MRR）
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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