Sulopenem SPM 2 µg
K号: K251879 · 2025-08-12
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器械摘要
Sulopenem SPM 2 µg is the device name listed in this FDA 510(k) record. The listed applicant is Liofilchem. It received FDA 510(k) clearance on 2025-08-12 under 510(k) number K251879. 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 Sulopenem SPM 2 µg?
Sulopenem SPM 2 µg is a medical device that received FDA 510(k) clearance on 2025-08-12. The listed applicant is Liofilchem. The 510(k) number is K251879.
When did Sulopenem SPM 2 µg receive FDA 510(k) clearance?
Sulopenem SPM 2 µg received FDA 510(k) clearance on 2025-08-12, under 510(k) number K251879.
Who is the listed applicant for Sulopenem SPM 2 µg?
The FDA 510(k) record lists Liofilchem as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Sulopenem SPM 2 µg?
The FDA product code for Sulopenem SPM 2 µg is JTN.
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：JTN）
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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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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