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FDA 510(k)

医疗器械监管政策：医疗设备监管规定- ADV坎塔特抗-CCP IgG (aCCP nâ´) 检测试剂包括试剂和校准材料、质量控制材料和曲线材料 nâ´

K号: K153551 · 2016-08-04

申请人Axis-Shield Diagnostics Limited
决定日期2016-08-04
产品代码NHX
咨询委员会抱歉，您提供的信息不完整，无法进行翻译。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

ADVIA Centaur Anti-CCP IgG (aCCP) assay including Reagents and Calibrators, Quality Controls and Master Curve Materials. is the device name listed in this FDA 510(k) record. The listed applicant is Axis-Shield Diagnostics Limited. It received FDA 510(k) clearance on 2016-08-04 under 510(k) number K153551. The device is classified under product code NHX. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the ADVIA Centaur Anti-CCP IgG (aCCP) assay including Reagents and Calibrators, Quality Controls and Master Curve Materials.?

ADVIA Centaur Anti-CCP IgG (aCCP) assay including Reagents and Calibrators, Quality Controls and Master Curve Materials. is a medical device that received FDA 510(k) clearance on 2016-08-04. The listed applicant is Axis-Shield Diagnostics Limited. The 510(k) number is K153551.

When did ADVIA Centaur Anti-CCP IgG (aCCP) assay including Reagents and Calibrators, Quality Controls and Master Curve Materials. receive FDA 510(k) clearance?

ADVIA Centaur Anti-CCP IgG (aCCP) assay including Reagents and Calibrators, Quality Controls and Master Curve Materials. received FDA 510(k) clearance on 2016-08-04, under 510(k) number K153551.

Who is the listed applicant for ADVIA Centaur Anti-CCP IgG (aCCP) assay including Reagents and Calibrators, Quality Controls and Master Curve Materials.?

The FDA 510(k) record lists Axis-Shield Diagnostics Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ADVIA Centaur Anti-CCP IgG (aCCP) assay including Reagents and Calibrators, Quality Controls and Master Curve Materials.?

The FDA product code for ADVIA Centaur Anti-CCP IgG (aCCP) assay including Reagents and Calibrators, Quality Controls and Master Curve Materials. is NHX.

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。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

列明Axis-Shield Diagnostics Limited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。

K183088ADVIA Centaur 红细胞生成素（EPO）测定K182012ADVIA Centaur 降钙素（CALCT）测定K160757ADVIA Centaur Active-B12 (全反式钴胺素)(AB12) 测定，ADVIA Centaur Active-B12(AB12) 质量控制，以及ADVIA Centaur Active-B12 (AB12) 主曲线材料（MCM）

官方来源

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