FDA 510(k)

Thermo Scientific Oxoid阿奇霉素/阿维巴坦药碟（30/20 µg）AZA50

K号: K250789 · 2025-06-12

申请人Thermo Fisher Scientific (Oxoid Ltd.)

决定日期2025-06-12

产品代码JTN

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决定实质等同

器械摘要

Thermo Scientific Oxoid Aztreonam/Avibactam Disc (30/20 µg) AZA50 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 2025-06-12 under 510(k) number K250789. 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 Aztreonam/Avibactam Disc (30/20 µg) AZA50?

Thermo Scientific Oxoid Aztreonam/Avibactam Disc (30/20 µg) AZA50 is a medical device that received FDA 510(k) clearance on 2025-06-12. The listed applicant is Thermo Fisher Scientific (Oxoid Ltd.). The 510(k) number is K250789.

When did Thermo Scientific Oxoid Aztreonam/Avibactam Disc (30/20 µg) AZA50 receive FDA 510(k) clearance?

Thermo Scientific Oxoid Aztreonam/Avibactam Disc (30/20 µg) AZA50 received FDA 510(k) clearance on 2025-06-12, under 510(k) number K250789.

Who is the listed applicant for Thermo Scientific Oxoid Aztreonam/Avibactam Disc (30/20 µg) AZA50?

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 Aztreonam/Avibactam Disc (30/20 µg) AZA50?

The FDA product code for Thermo Scientific Oxoid Aztreonam/Avibactam Disc (30/20 µg) AZA50 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 K251337Thermo Scientific Oxoid吉他他滨药碟（10 µg）GEP10

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