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FDA 510(k)

Alinity 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

K号: K230790 · 2023-05-19

申请人Abbott Laboratories
决定日期2023-05-19
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

Alinity i Total B-hCG Reagent Kit, Alinity c Glucose Reagent Kit, Alinity c ICT Sample Diluent, Alinity ci-series is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 2023-05-19 under 510(k) number K230790. 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 Alinity i Total B-hCG Reagent Kit, Alinity c Glucose Reagent Kit, Alinity c ICT Sample Diluent, Alinity ci-series?

Alinity i Total B-hCG Reagent Kit, Alinity c Glucose Reagent Kit, Alinity c ICT Sample Diluent, Alinity ci-series is a medical device that received FDA 510(k) clearance on 2023-05-19. The listed applicant is Abbott Laboratories. The 510(k) number is K230790.

When did Alinity i Total B-hCG Reagent Kit, Alinity c Glucose Reagent Kit, Alinity c ICT Sample Diluent, Alinity ci-series receive FDA 510(k) clearance?

Alinity i Total B-hCG Reagent Kit, Alinity c Glucose Reagent Kit, Alinity c ICT Sample Diluent, Alinity ci-series received FDA 510(k) clearance on 2023-05-19, under 510(k) number K230790.

Who is the listed applicant for Alinity i Total B-hCG Reagent Kit, Alinity c Glucose Reagent Kit, Alinity c ICT Sample Diluent, Alinity ci-series?

FDA 510(k)记录显示，申请人为阿伯特实验室。这本身并不能确立该设备的制造商。

What is the FDA product code for Alinity i Total B-hCG Reagent Kit, Alinity c Glucose Reagent Kit, Alinity c ICT Sample Diluent, Alinity ci-series?

The FDA product code for Alinity i Total B-hCG Reagent Kit, Alinity c Glucose Reagent Kit, Alinity c ICT Sample Diluent, Alinity ci-series 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

列明Abbott Laboratories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。

K262156抗HCV NextK252424抗HCV NextK243500ARCHITECT 链霉素K243168Alinity i 风疹IgGK243283Alinity h系列系统K233932Alinity i Toxo IgM

查看所有 28 个设备 →

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 DiagnosticsK223690iFlash-HCG; 化学发光免疫分析仪（型号：iFlash 3000-C）Shenzhen Yhlo Biotech Co., Ltd.K230937Alinity i 总β-hCG试剂套件，GLP系统追踪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

在 FDA 数据库中查看 →

数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。

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