ARCHITECT 链霉素
K号: K243500 · 2025-07-09
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决定日期2025-07-09
产品代码LCD
咨询委员会TX
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决定实质等同
器械摘要
ARCHITECT iGentamicin is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 2025-07-09 under 510(k) number K243500. The device is classified under product code LCD. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the ARCHITECT iGentamicin?
ARCHITECT iGentamicin is a medical device that received FDA 510(k) clearance on 2025-07-09. The listed applicant is Abbott Laboratories. The 510(k) number is K243500.
When did ARCHITECT iGentamicin receive FDA 510(k) clearance?
ARCHITECT iGentamicin received FDA 510(k) clearance on 2025-07-09, under 510(k) number K243500.
Who is the listed applicant for ARCHITECT iGentamicin?
FDA 510(k)记录显示，申请人为阿伯特实验室。这本身并不能确立该设备的制造商。
What is the FDA product code for ARCHITECT iGentamicin?
The FDA product code for ARCHITECT iGentamicin is LCD.
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。
列明Abbott Laboratories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。
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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