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FDA 510(k)

Thermo Scientific Oxoid美罗培南/伐布坦药碟（30µg）MEV30

K号: K181975 · 2018-09-27

申请人Oxoid Limited (Part of Thermo Fisher Scientific)
决定日期2018-09-27
产品代码JTN
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决定实质等同

器械摘要

Thermo Scientific Oxoid Meropenem/Vaborbactam Disc (30µg) MEV30 is the device name listed in this FDA 510(k) record. The listed applicant is Oxoid Limited (Part of Thermo Fisher Scientific). It received FDA 510(k) clearance on 2018-09-27 under 510(k) number K181975. 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 Thermo Scientific Oxoid Meropenem/Vaborbactam Disc (30µg) MEV30?

Thermo Scientific Oxoid Meropenem/Vaborbactam Disc (30µg) MEV30 is a medical device that received FDA 510(k) clearance on 2018-09-27. The listed applicant is Oxoid Limited (Part of Thermo Fisher Scientific). The 510(k) number is K181975.

When did Thermo Scientific Oxoid Meropenem/Vaborbactam Disc (30µg) MEV30 receive FDA 510(k) clearance?

Thermo Scientific Oxoid Meropenem/Vaborbactam Disc (30µg) MEV30 received FDA 510(k) clearance on 2018-09-27, under 510(k) number K181975.

Who is the listed applicant for Thermo Scientific Oxoid Meropenem/Vaborbactam Disc (30µg) MEV30?

The FDA 510(k) record lists Oxoid Limited (Part of Thermo Fisher Scientific) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Thermo Scientific Oxoid Meropenem/Vaborbactam Disc (30µg) MEV30?

The FDA product code for Thermo Scientific Oxoid Meropenem/Vaborbactam Disc (30µg) MEV30 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。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

列明Oxoid Limited (Part of Thermo Fisher Scientific)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。

K231806Thermo Scientific Oxoid雷扎芬净药碟（5 µg）RZF5K232276Thermo Scientific Oxoid舒巴坦/杜洛巴坦药碟（10/10 µg）SUD20K203336Thermo Scientific Oxoid奥马环素药碟（30 ug）OMC30K210873Thermo Scientific Oxoid来氟米星药碟（20µg）LMU20K203700Thermo Scientific Oxoid头孢吡肟药碟（30 µg）FDC30K193508Thermo Scientific Oxoid厄他环素药碟（20ug）ERV20

查看所有 7 个设备 →

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

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