FDA 510(k)

ADVIA 2120i, ADVIA 2120

K号: K162977 · 2017-08-11

决定日期2017-08-11

产品代码GKZ

咨询委员会HE 请注意，由于您只提供了“HE”作为输入，我无法提供完整的翻译。请提供完整的描述或文本，以便我能够进行准确的翻译。

决定实质等同

器械摘要

ADVIA 2120i, ADVIA 2120 is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Healthcare Diagnostics. It received FDA 510(k) clearance on 2017-08-11 under 510(k) number K162977. The device is classified under product code GKZ. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the ADVIA 2120i, ADVIA 2120?

ADVIA 2120i, ADVIA 2120 is a medical device that received FDA 510(k) clearance on 2017-08-11. The listed applicant is Siemens Healthcare Diagnostics. The 510(k) number is K162977.

When did ADVIA 2120i, ADVIA 2120 receive FDA 510(k) clearance?

ADVIA 2120i, ADVIA 2120 received FDA 510(k) clearance on 2017-08-11, under 510(k) number K162977.

Who is the listed applicant for ADVIA 2120i, ADVIA 2120?

The FDA 510(k) record lists Siemens Healthcare Diagnostics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ADVIA 2120i, ADVIA 2120?

The FDA product code for ADVIA 2120i, ADVIA 2120 is GKZ.

列明Siemens Healthcare 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。

K243570Dimension LOCI促甲状腺激素灵活试剂盒（TSHL）；Dimension LOCI游离甲状腺素灵活试剂盒（FT4L）K162298LOCI 总维生素D总测定，LOCI VITD CAL K161954Atellica Solution, Atellica A-LYTE 集成多传感器 Na+/K+/CI-, Atellica CH 白蛋白BCP试剂 (Alb_p), Atellica IM 促甲状腺激素 TSH, Atellica CH 万古霉素 (Vanc)K162538ADVIA Centaur 胰岛素（IRI）主曲线材料（MCM），ADVIA Centaur（IRI）校准器 K151964Xprecia Stride 凝血系统，Xprecia 系统 PT 控制

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。