Ceftobiprole BPR 5 µg 圆盘
K号: K250885 · 2025-06-23
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决定日期2025-06-23
产品代码JTN
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器械摘要
Ceftobiprole BPR 5 µg Disc is the device name listed in this FDA 510(k) record. The listed applicant is Liofilchem, Inc.. It received FDA 510(k) clearance on 2025-06-23 under 510(k) number K250885. 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 Ceftobiprole BPR 5 µg Disc?
Ceftobiprole BPR 5 µg Disc is a medical device that received FDA 510(k) clearance on 2025-06-23. The listed applicant is Liofilchem, Inc.. The 510(k) number is K250885.
When did Ceftobiprole BPR 5 µg Disc receive FDA 510(k) clearance?
Ceftobiprole BPR 5 µg Disc received FDA 510(k) clearance on 2025-06-23, under 510(k) number K250885.
Who is the listed applicant for Ceftobiprole BPR 5 µg Disc?
FDA 510(k)记录列出的申请人是Liofilchem, Inc.。这本身并不足以确立该设备制造商。
What is the FDA product code for Ceftobiprole BPR 5 µg Disc?
The FDA product code for Ceftobiprole BPR 5 µg Disc 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。
列明Liofilchem, Inc.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。
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。
K262113HardyDisk AST 泰比培南 10µg（TBP10）Hardy DiagnosticsK261781Thermo Scientific Oxoid 头孢哌酮/替达泊芬姆药碟（30/30 µg）FPZ60Thermo Fisher Scientific (Oxoid Ltd.)K261853Gepotidacin GEP 10 µgLiofilchem, Inc.K260842HardyDisk AST Gepotidacin 10µg (GEP10)Hardy DiagnosticsK251337Thermo Scientific Oxoid吉他他滨药碟（10 µg）GEP10Thermo Fisher Scientific (Oxoid Ltd.)K253105HardyDisk AST Cefiderocol 30µg (FDC30)Hardy Diagnostics
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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