FDA 510(k)

Thermo Scientific Oxoid雷扎芬净药碟（5 µg）RZF5

K号: K231806 · 2024-03-22

申请人Oxoid Limited (Part of Thermo Fisher Scientific)

决定日期2024-03-22

产品代码JTN

咨询委员会抱歉，您提供的内容“MI”不足以进行翻译。请提供完整的医疗设备监管文本，以便我能够进行准确的翻译。

决定实质等同

器械摘要

Thermo Scientific Oxoid Rezafungin Disc (5 µg) RZF5 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 2024-03-22 under 510(k) number K231806. 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 Rezafungin Disc (5 µg) RZF5?

Thermo Scientific Oxoid Rezafungin Disc (5 µg) RZF5 is a medical device that received FDA 510(k) clearance on 2024-03-22. The listed applicant is Oxoid Limited (Part of Thermo Fisher Scientific). The 510(k) number is K231806.

When did Thermo Scientific Oxoid Rezafungin Disc (5 µg) RZF5 receive FDA 510(k) clearance?

Thermo Scientific Oxoid Rezafungin Disc (5 µg) RZF5 received FDA 510(k) clearance on 2024-03-22, under 510(k) number K231806.

Who is the listed applicant for Thermo Scientific Oxoid Rezafungin Disc (5 µg) RZF5?

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 Rezafungin Disc (5 µg) RZF5?

The FDA product code for Thermo Scientific Oxoid Rezafungin Disc (5 µg) RZF5 is JTN.

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。

K232276Thermo Scientific Oxoid舒巴坦/杜洛巴坦药碟（10/10 µg）SUD20 K203336Thermo Scientific Oxoid奥马环素药碟（30 ug）OMC30 K210873Thermo Scientific Oxoid来氟米星药碟（20µg）LMU20 K203700Thermo Scientific Oxoid头孢吡肟药碟（30 µg）FDC30 K193508Thermo Scientific Oxoid厄他环素药碟（20ug）ERV20 K181975Thermo Scientific Oxoid美罗培南/伐布坦药碟（30µg）MEV30

查看所有 7 个设备 →

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。