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FDA 510(k)

ELITech 临床系统 GLUCOSE HK SL，ELITech 临床系统 ELICAL 2，ELITech 临床系统 ELITROL I 和 ELITROL II

K号: K153644 · 2016-09-07

申请人Elitechgroup
决定日期2016-09-07
产品代码CFR
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

ELITech Clinical Systems GLUCOSE HK SL, ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I and ELITROL II is the device name listed in this FDA 510(k) record. The listed applicant is Elitechgroup. It received FDA 510(k) clearance on 2016-09-07 under 510(k) number K153644. The device is classified under product code CFR. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the ELITech Clinical Systems GLUCOSE HK SL, ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I and ELITROL II?

ELITech Clinical Systems GLUCOSE HK SL, ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I and ELITROL II is a medical device that received FDA 510(k) clearance on 2016-09-07. The listed applicant is Elitechgroup. The 510(k) number is K153644.

When did ELITech Clinical Systems GLUCOSE HK SL, ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I and ELITROL II receive FDA 510(k) clearance?

ELITech Clinical Systems GLUCOSE HK SL, ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I and ELITROL II received FDA 510(k) clearance on 2016-09-07, under 510(k) number K153644.

Who is the listed applicant for ELITech Clinical Systems GLUCOSE HK SL, ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I and ELITROL II?

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

What is the FDA product code for ELITech Clinical Systems GLUCOSE HK SL, ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I and ELITROL II?

The FDA product code for ELITech Clinical Systems GLUCOSE HK SL, ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I and ELITROL II is CFR.

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Elitechgroup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。

K180559HSV 1 & 2 ELITe MGB 套件; ELITe InGeniusK171401ELITech 临床系统 BILIRUBIN TOTAL 4+1，ELITech 临床系统 BILIRUBIN DIRECT 4+1

相关器械（代码：CFR）

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。

K253490Glucose HK Gen.3；ONLINE DAT Methadone II；cobas pro 集成解决方案Roche DiagnosticsK252357Glucose2Abbott IrelandK220134科博斯纯集成解决方案，葡萄糖HK Gen.3，ISE间接钠Gen.2，在线DAT美沙酮II，Elecsys促甲状腺激素Roche DiagnosticsK191899Glucose HK Gen.3，ISE 间接钠离子检测 Gen.2，Elecsys TSH，cobas pro 集成解决方案Roche DiagnosticsK170316ALINITY C葡萄糖试剂套件，ALINITY C系统Abbott LaboratoriesK151487Diatron Pictus 700 临床化学分析仪，Diatron ISE，Diatron 葡萄糖己糖激酶法Diatron U.S., Inc.

官方来源

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