FDA 510(k)

Xprecia Stride 凝血系统，Xprecia 系统 PT 控制

K号: K151964 · 2016-09-30

决定日期2016-09-30

产品代码GJS

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决定实质等同

器械摘要

Xprecia Stride Coagulation System, Xprecia System PT Controls 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 2016-09-30 under 510(k) number K151964. The device is classified under product code GJS. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Xprecia Stride Coagulation System, Xprecia System PT Controls?

Xprecia Stride Coagulation System, Xprecia System PT Controls is a medical device that received FDA 510(k) clearance on 2016-09-30. The listed applicant is Siemens Healthcare Diagnostics. The 510(k) number is K151964.

When did Xprecia Stride Coagulation System, Xprecia System PT Controls receive FDA 510(k) clearance?

Xprecia Stride Coagulation System, Xprecia System PT Controls received FDA 510(k) clearance on 2016-09-30, under 510(k) number K151964.

Who is the listed applicant for Xprecia Stride Coagulation System, Xprecia System PT Controls?

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 Xprecia Stride Coagulation System, Xprecia System PT Controls?

The FDA product code for Xprecia Stride Coagulation System, Xprecia System PT Controls is GJS.

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）K162977ADVIA 2120i, ADVIA 2120 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

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