FDA 510(k)

BD Phoenix® 自动微生物学系统

K号: K250344 · 2025-03-06

决定日期2025-03-06

产品代码LON

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决定实质等同

器械摘要

BD Phoenix™ Automated Microbiology System 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 2025-03-06 under 510(k) number K250344. 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?

BD Phoenix™ Automated Microbiology System is a medical device that received FDA 510(k) clearance on 2025-03-06. The listed applicant is Becton, Dickinson and Company. The 510(k) number is K250344.

When did BD Phoenix™ Automated Microbiology System receive FDA 510(k) clearance?

BD Phoenix™ Automated Microbiology System received FDA 510(k) clearance on 2025-03-06, under 510(k) number K250344.

Who is the listed applicant for BD Phoenix™ Automated Microbiology System?

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?

The FDA product code for BD Phoenix™ Automated Microbiology System is LON.

列明Becton, Dickinson and Company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。

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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）BIOMERIEUX K251579VITEK 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 Company K250447BD 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）Becton, Dickinson and Company K234012VITEK COMPACT PRObioMerieux, Inc.

官方来源

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