免责声明: 本站汇总 FDA、ClinicalTrials.gov、PubMed、SEC EDGAR 等官方公开数据，仅供一般参考，不构成医疗建议、诊断、治疗建议或投资建议。

FDA 510(k)

MAGLUMI 2000 TSH, MAGLUMI 2000 免疫分析仪

K号: K162698 · 2017-07-14

申请人Shenzhen New Industries Biomedical Engineering Co., Ltd.
决定日期2017-07-14
产品代码JLW
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

MAGLUMI 2000 TSH, MAGLUMI 2000 Immunoassay Analyzer is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen New Industries Biomedical Engineering Co., Ltd.. It received FDA 510(k) clearance on 2017-07-14 under 510(k) number K162698. The device is classified under product code JLW. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the MAGLUMI 2000 TSH, MAGLUMI 2000 Immunoassay Analyzer?

MAGLUMI 2000 TSH, MAGLUMI 2000 Immunoassay Analyzer is a medical device that received FDA 510(k) clearance on 2017-07-14. The listed applicant is Shenzhen New Industries Biomedical Engineering Co., Ltd.. The 510(k) number is K162698.

When did MAGLUMI 2000 TSH, MAGLUMI 2000 Immunoassay Analyzer receive FDA 510(k) clearance?

MAGLUMI 2000 TSH, MAGLUMI 2000 Immunoassay Analyzer received FDA 510(k) clearance on 2017-07-14, under 510(k) number K162698.

Who is the listed applicant for MAGLUMI 2000 TSH, MAGLUMI 2000 Immunoassay Analyzer?

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

What is the FDA product code for MAGLUMI 2000 TSH, MAGLUMI 2000 Immunoassay Analyzer?

The FDA product code for MAGLUMI 2000 TSH, MAGLUMI 2000 Immunoassay Analyzer is JLW.

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Shenzhen New Industries Biomedical Engineering Co., Ltd.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。

K232587MAGLUMI 25-OH 维生素D, MAGLUMI X3 全自动化学发光免疫分析仪K192547MAGLUMI 2000 HCG/ß-HCGK191499MAGLUMI 2000 25-OH 维生素DK182423MAGLUMI 2000 FT4

相关器械（代码：JLW）

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。

K251543Atellica® IM TSH3-Ultra II (TSH3ULII)Siemens Healthcare Diagnostics, Inc.K243570Dimension LOCI促甲状腺激素灵活试剂盒（TSHL）；Dimension LOCI游离甲状腺素灵活试剂盒（FT4L）Siemens Healthcare DiagnosticsK234091Maverick诊断系统TC1000；Maverick测试面板A0.B0Genalyte, Inc.K233050ADVIA Centaur® TSH3-Ultra II (TSH3ULII)Siemens Healthcare Diagnostics, Inc.K222116Atellica® CI 分析仪, Atellica® IM 促甲状腺激素 3-Ultra (TSH3-UL), Atellica® CH 白蛋白BCP (AlbP)Siemens Healthcare Diagnostics, Inc.K221225Access TSH (3rd IS) 测定，DxI 9000 Access 免疫测定分析仪Beckman Coulter, Inc.

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。

↑