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FDA 510(k)

INNOVANCE(r) 肝素试剂，INNOVANCE(r) 肝素校准器，INNOVANCE(r) 肝素UF和肝素LMW对照品

K号: K162540 · 2017-08-22

申请人Siemens Healthcare Diagnostics Prodcts GmbH
决定日期2017-08-22
产品代码KFF
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

INNOVANCE(r) Heparin Reagents, INNOVANCE(r) Heparin Calibrator, INNOVANCE(r) Heparin UF and Heparin LMW Controls is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Healthcare Diagnostics Prodcts GmbH. It received FDA 510(k) clearance on 2017-08-22 under 510(k) number K162540. The device is classified under product code KFF. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the INNOVANCE(r) Heparin Reagents, INNOVANCE(r) Heparin Calibrator, INNOVANCE(r) Heparin UF and Heparin LMW Controls?

INNOVANCE(r) Heparin Reagents, INNOVANCE(r) Heparin Calibrator, INNOVANCE(r) Heparin UF and Heparin LMW Controls is a medical device that received FDA 510(k) clearance on 2017-08-22. The listed applicant is Siemens Healthcare Diagnostics Prodcts GmbH. The 510(k) number is K162540.

When did INNOVANCE(r) Heparin Reagents, INNOVANCE(r) Heparin Calibrator, INNOVANCE(r) Heparin UF and Heparin LMW Controls receive FDA 510(k) clearance?

INNOVANCE(r) Heparin Reagents, INNOVANCE(r) Heparin Calibrator, INNOVANCE(r) Heparin UF and Heparin LMW Controls received FDA 510(k) clearance on 2017-08-22, under 510(k) number K162540.

Who is the listed applicant for INNOVANCE(r) Heparin Reagents, INNOVANCE(r) Heparin Calibrator, INNOVANCE(r) Heparin UF and Heparin LMW Controls?

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

What is the FDA product code for INNOVANCE(r) Heparin Reagents, INNOVANCE(r) Heparin Calibrator, INNOVANCE(r) Heparin UF and Heparin LMW Controls?

The FDA product code for INNOVANCE(r) Heparin Reagents, INNOVANCE(r) Heparin Calibrator, INNOVANCE(r) Heparin UF and Heparin LMW Controls is KFF.

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

相关器械（代码：KFF）

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。

K260214STA® - 液体抗XaDiagnostica Stago, Inc.K213464HemosIL 液体抗-XaInstrumentation Laboratory CO

官方来源

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