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FDA 510(k)

综合代谢面板，skyla临床化学分析仪，Minicare C300临床化学分析仪

K号: K171971 · 2018-01-25

申请人Lite-On Technology Corp. H.S.P.B.
决定日期2018-01-25
产品代码CJE
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

Comprehensive Metabolic Panel, skyla Clinical Chemistry Analyzer, Minicare C300 Clinical Chemistry Analyzer is the device name listed in this FDA 510(k) record. The listed applicant is Lite-On Technology Corp. H.S.P.B.. It received FDA 510(k) clearance on 2018-01-25 under 510(k) number K171971. The device is classified under product code CJE. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Comprehensive Metabolic Panel, skyla Clinical Chemistry Analyzer, Minicare C300 Clinical Chemistry Analyzer?

Comprehensive Metabolic Panel, skyla Clinical Chemistry Analyzer, Minicare C300 Clinical Chemistry Analyzer is a medical device that received FDA 510(k) clearance on 2018-01-25. The listed applicant is Lite-On Technology Corp. H.S.P.B.. The 510(k) number is K171971.

When did Comprehensive Metabolic Panel, skyla Clinical Chemistry Analyzer, Minicare C300 Clinical Chemistry Analyzer receive FDA 510(k) clearance?

Comprehensive Metabolic Panel, skyla Clinical Chemistry Analyzer, Minicare C300 Clinical Chemistry Analyzer received FDA 510(k) clearance on 2018-01-25, under 510(k) number K171971.

Who is the listed applicant for Comprehensive Metabolic Panel, skyla Clinical Chemistry Analyzer, Minicare C300 Clinical Chemistry Analyzer?

The FDA 510(k) record lists Lite-On Technology Corp. H.S.P.B. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Comprehensive Metabolic Panel, skyla Clinical Chemistry Analyzer, Minicare C300 Clinical Chemistry Analyzer?

The FDA product code for Comprehensive Metabolic Panel, skyla Clinical Chemistry Analyzer, Minicare C300 Clinical Chemistry Analyzer is CJE.

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：CJE）

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。

K251074Tru Liver Health Test PanelTruvian HealthK240468碱性磷酸酶Abbott Laboratories Diagnostics DivisionK223317碱性磷酸酶2Abbott Ireland Diagnostics DivisionK191245优米森C1200 ALP，优米森C1200白蛋白HORIBA ABX SASK171080ALP IFCC Gen.2Roche Diagnostics Operations (Rdo)K162275Randox RX Daytona Plus 碱性磷酸酶 (ALP)Randox Laboratories Limited

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