FDA 510(k)

Thermo Scientific Oxoid 遮菌素膠碟 (5 µg) RZF5

K 號：K231806 · 2024-03-22

申請人Oxoid Limited (Part of Thermo Fisher Scientific)

決定日期2024-03-22

產品代碼JTN

諮詢委員會MI (請提供完整的描述文本，以便進行翻譯。)

決定相當於

器材摘要

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.

常見問題

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.

其他以 Oxoid Limited (Part of Thermo Fisher Scientific) 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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相關器械（代碼：JTN）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K262113HardyDisk AST 蓋培南 10µg (TBP10)Hardy Diagnostics K261781Thermo Scientific Oxoid 葛拉西林/替卡西林膠片 (30/30 µg) FPZ60Thermo Fisher Scientific (Oxoid Ltd.)K261853Gepotidacin GEP 10 µgLiofilchem, Inc.K260842HardyDisk AST Gepotidacin 10µg (GEP10)Hardy Diagnostics K251337Thermo Scientific Oxoid Gepotidacin 盤片 (10 µg) GEP10Thermo Fisher Scientific (Oxoid Ltd.)K253105HardyDisk AST 萬古霉素 30µg (FDC30)Hardy Diagnostics

官方來源

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