FDA 510(k)

HardyDisk AST Gepotidacin 10µg (GEP10)

K号: K260842 · 2026-05-11

决定日期2026-05-11

产品代码JTN

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决定实质等同

器械摘要

HardyDisk AST Gepotidacin 10µg (GEP10) is the device name listed in this FDA 510(k) record. The listed applicant is Hardy Diagnostics. It received FDA 510(k) clearance on 2026-05-11 under 510(k) number K260842. 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 AST Gepotidacin 10µg (GEP10)?

HardyDisk AST Gepotidacin 10µg (GEP10) is a medical device that received FDA 510(k) clearance on 2026-05-11. The listed applicant is Hardy Diagnostics. The 510(k) number is K260842.

When did HardyDisk AST Gepotidacin 10µg (GEP10) receive FDA 510(k) clearance?

HardyDisk AST Gepotidacin 10µg (GEP10) received FDA 510(k) clearance on 2026-05-11, under 510(k) number K260842.

Who is the listed applicant for HardyDisk AST Gepotidacin 10µg (GEP10)?

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 AST Gepotidacin 10µg (GEP10)?

The FDA product code for HardyDisk AST Gepotidacin 10µg (GEP10) 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）K253105HardyDisk AST Cefiderocol 30µg (FDC30)K250956HardyDisk AST Gepotidacin 10µg (GEP10)K250454HardyDisk Aztreonam/Avibactam 30/20µg (AZA50)K233534病毒运输培养基 K241060HardyDisk AST Cefiderocol 30µg (FDC30)

查看所有 23 个设备 →

官方来源

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