BD BACTEC FXI 培养系统
K号: K260213 · 2026-05-28
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决定日期2026-05-28
产品代码MDB
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器械摘要
BD BACTEC FXI Culture System is the device name listed in this FDA 510(k) record. The listed applicant is BD Diagnostic Systems. It received FDA 510(k) clearance on 2026-05-28 under 510(k) number K260213. The device is classified under product code MDB. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the BD BACTEC FXI Culture System?
BD BACTEC FXI Culture System is a medical device that received FDA 510(k) clearance on 2026-05-28. The listed applicant is BD Diagnostic Systems. The 510(k) number is K260213.
When did BD BACTEC FXI Culture System receive FDA 510(k) clearance?
BD BACTEC FXI Culture System received FDA 510(k) clearance on 2026-05-28, under 510(k) number K260213.
Who is the listed applicant for BD BACTEC FXI Culture System?
The FDA 510(k) record lists BD Diagnostic Systems as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for BD BACTEC FXI Culture System?
The FDA product code for BD BACTEC FXI Culture System is MDB.
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。
相关器械（代码：MDB）
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。
K222559BD BACTEC™ Myco/F 溶解培养管Becton, Dickinson and CompanyK222591BD BACTEC™ Plus 好氧/F 培养管Becton, Dickinson and CompanyK190405BACT/ALERT MP 试剂系统bioMerieux, Inc.K183166BacT/ALERT FA Plus; BacT/ALERT PF PlusbioMerieux, Inc.K173873BD BACTEC Peds Plus/F 培养管大豆-酪蛋白消化液，塑料管中含树脂Becton, Dickinson and CompanyK161816BacT/ALERT VIRTUO 微生物检测系统，BacT/ALERT VIRTUO，VIRTUObioMerieux, 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。
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