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FDA 510(k)

iFlash-HCG; 化学发光免疫分析仪（型号：iFlash 3000-C）

K号: K223690 · 2023-12-11

申请人Shenzhen Yhlo Biotech Co., Ltd.
决定日期2023-12-11
产品代码DHA
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

iFlash-HCG; Chemiluminescence Immunoassay Analyzer (Model: iFlash 3000-C) is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Yhlo Biotech Co., Ltd.. It received FDA 510(k) clearance on 2023-12-11 under 510(k) number K223690. The device is classified under product code DHA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the iFlash-HCG; Chemiluminescence Immunoassay Analyzer (Model: iFlash 3000-C)?

iFlash-HCG; Chemiluminescence Immunoassay Analyzer (Model: iFlash 3000-C) is a medical device that received FDA 510(k) clearance on 2023-12-11. The listed applicant is Shenzhen Yhlo Biotech Co., Ltd.. The 510(k) number is K223690.

When did iFlash-HCG; Chemiluminescence Immunoassay Analyzer (Model: iFlash 3000-C) receive FDA 510(k) clearance?

iFlash-HCG; Chemiluminescence Immunoassay Analyzer (Model: iFlash 3000-C) received FDA 510(k) clearance on 2023-12-11, under 510(k) number K223690.

Who is the listed applicant for iFlash-HCG; Chemiluminescence Immunoassay Analyzer (Model: iFlash 3000-C)?

The FDA 510(k) record lists Shenzhen Yhlo Biotech Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for iFlash-HCG; Chemiluminescence Immunoassay Analyzer (Model: iFlash 3000-C)?

The FDA product code for iFlash-HCG; Chemiluminescence Immunoassay Analyzer (Model: iFlash 3000-C) is DHA.

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：DHA）

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。

K233581VITROS 免疫诊断产品 总β-hCG II 试剂套装Ortho Clinical DiagnosticsK230937Alinity i 总β-hCG试剂套件，GLP系统追踪Abbott LaboratoriesK230790Alinity i 总β-hCG试剂套件，Alinity c 葡萄糖试剂套件，Alinity c ICT样本稀释液，Alinity ci系列Abbott LaboratoriesK221990Access 总βhCG (5th IS)Beckman Coulter, Inc.K212221Diazyme DZ-Lite iFlash 总β-hCG 测定，Diazyme DZ-Lite iFlash 1800 化学发光免疫测定分析仪Diazyme Laboratories, Inc.K203227Elecsys HCG STATRoche Diagnostics

官方来源

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