FDA 510(k)

Thermo Scientific Oxoid吉他他滨药碟（10 µg）GEP10

K号: K251337 · 2025-12-05

申请人Thermo Fisher Scientific (Oxoid Ltd.)

决定日期2025-12-05

产品代码JTN

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决定实质等同

器械摘要

Thermo Scientific Oxoid Gepotidacin Disc (10 µg) GEP10 is the device name listed in this FDA 510(k) record. The listed applicant is Thermo Fisher Scientific (Oxoid Ltd.). It received FDA 510(k) clearance on 2025-12-05 under 510(k) number K251337. 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 Gepotidacin Disc (10 µg) GEP10?

Thermo Scientific Oxoid Gepotidacin Disc (10 µg) GEP10 is a medical device that received FDA 510(k) clearance on 2025-12-05. The listed applicant is Thermo Fisher Scientific (Oxoid Ltd.). The 510(k) number is K251337.

When did Thermo Scientific Oxoid Gepotidacin Disc (10 µg) GEP10 receive FDA 510(k) clearance?

Thermo Scientific Oxoid Gepotidacin Disc (10 µg) GEP10 received FDA 510(k) clearance on 2025-12-05, under 510(k) number K251337.

Who is the listed applicant for Thermo Scientific Oxoid Gepotidacin Disc (10 µg) GEP10?

FDA 510(k)记录将赛默飞世尔科技（Oxoid Ltd.）列为申请人。这本身并不足以确立该设备的制造商。

What is the FDA product code for Thermo Scientific Oxoid Gepotidacin Disc (10 µg) GEP10?

The FDA product code for Thermo Scientific Oxoid Gepotidacin Disc (10 µg) GEP10 is JTN.

列明Thermo Fisher Scientific (Oxoid Ltd.)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。

K261781Thermo Scientific Oxoid 头孢哌酮/替达泊芬姆药碟（30/30 µg）FPZ60 K250789Thermo Scientific Oxoid阿奇霉素/阿维巴坦药碟（30/20 µg）AZA50

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