FDA 510(k)

HardyDisk Aztreonam/Avibactam 30/20µg (AZA50)

K号: K250454 · 2025-05-15

决定日期2025-05-15

产品代码JTN

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决定实质等同

器械摘要

HardyDisk Aztreonam/Avibactam 30/20µg (AZA50) is the device name listed in this FDA 510(k) record. The listed applicant is Hardy Diagnostics. It received FDA 510(k) clearance on 2025-05-15 under 510(k) number K250454. The device is classified under product code JTN. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the HardyDisk Aztreonam/Avibactam 30/20µg (AZA50)?

HardyDisk Aztreonam/Avibactam 30/20µg (AZA50) is a medical device that received FDA 510(k) clearance on 2025-05-15. The listed applicant is Hardy Diagnostics. The 510(k) number is K250454.

When did HardyDisk Aztreonam/Avibactam 30/20µg (AZA50) receive FDA 510(k) clearance?

HardyDisk Aztreonam/Avibactam 30/20µg (AZA50) received FDA 510(k) clearance on 2025-05-15, under 510(k) number K250454.

Who is the listed applicant for HardyDisk Aztreonam/Avibactam 30/20µg (AZA50)?

FDA 510(k)记录显示Hardy Diagnostics为申请人。这本身并不能确立该设备制造商的身份。

What is the FDA product code for HardyDisk Aztreonam/Avibactam 30/20µg (AZA50)?

The FDA product code for HardyDisk Aztreonam/Avibactam 30/20µg (AZA50) is JTN.

列明Hardy Diagnostics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。

K262113HardyDisk AST 泰比培南 10µg（TBP10）K260842HardyDisk AST Gepotidacin 10µg (GEP10)K253105HardyDisk AST Cefiderocol 30µg (FDC30)K250956HardyDisk AST Gepotidacin 10µg (GEP10)K233534病毒运输培养基 K241060HardyDisk AST Cefiderocol 30µg (FDC30)

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官方来源

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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。