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FDA 510(k)

BD Phoenix® 自动微生物学系统 - GN 亚胺培南-雷巴匹坦（0.0625/4 - 16/4 µg/mL）

K号: K250447 · 2025-05-19

申请人Becton, Dickinson and Company
决定日期2025-05-19
产品代码LON
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决定实质等同

器械摘要

BD Phoenix™ Automated Microbiology System - GN Imipenem-relebactam (0.0625/4 - 16/4 µg/mL) is the device name listed in this FDA 510(k) record. The listed applicant is Becton, Dickinson and Company. It received FDA 510(k) clearance on 2025-05-19 under 510(k) number K250447. The device is classified under product code LON. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the BD Phoenix™ Automated Microbiology System - GN Imipenem-relebactam (0.0625/4 - 16/4 µg/mL)?

BD Phoenix™ Automated Microbiology System - GN Imipenem-relebactam (0.0625/4 - 16/4 µg/mL) is a medical device that received FDA 510(k) clearance on 2025-05-19. The listed applicant is Becton, Dickinson and Company. The 510(k) number is K250447.

When did BD Phoenix™ Automated Microbiology System - GN Imipenem-relebactam (0.0625/4 - 16/4 µg/mL) receive FDA 510(k) clearance?

BD Phoenix™ Automated Microbiology System - GN Imipenem-relebactam (0.0625/4 - 16/4 µg/mL) received FDA 510(k) clearance on 2025-05-19, under 510(k) number K250447.

Who is the listed applicant for BD Phoenix™ Automated Microbiology System - GN Imipenem-relebactam (0.0625/4 - 16/4 µg/mL)?

The FDA 510(k) record lists Becton, Dickinson and Company as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BD Phoenix™ Automated Microbiology System - GN Imipenem-relebactam (0.0625/4 - 16/4 µg/mL)?

The FDA product code for BD Phoenix™ Automated Microbiology System - GN Imipenem-relebactam (0.0625/4 - 16/4 µg/mL) is LON.

相关临床试验

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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

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相关器械（代码：LON）

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。

K260282VITEK 2 AST-诱导克林霉素耐药性链球菌bioMerieux, Inc.K260281VITEK 2 AST-链球菌头孢呋辛（<=0.125 - >=8 µg/mL）BIOMERIEUXK251579VITEK 2 AST-革兰氏阴性头孢唑啉（=<1-=>32 µg/mL）bioMerieux, Inc.K251713BD Phoenix 自动微生物学系统 - GN 恩拉韦环素（0.125-2 µg/mL）Becton, Dickinson and CompanyK234012VITEK COMPACT PRObioMerieux, Inc.K250344BD Phoenix® 自动微生物学系统Becton, Dickinson and Company

官方来源

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