FDA 510(k)

Thermo Scientific Oxoid Gepotidacin 盤片 (10 µg) GEP10

K 號：K251337 · 2025-12-05

申請人Thermo Fisher Scientific (Oxoid Ltd.)

決定日期2025-12-05

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 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.

常見問題

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) 記錄將 Thermo Fisher Scientific (Oxoid Ltd.) 列為申請人。這並不單獨確立設備製造商。

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.

其他以 Thermo Fisher Scientific (Oxoid Ltd.) 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。

K261781Thermo Scientific Oxoid 葛拉西林/替卡西林膠片 (30/30 µg) FPZ60 K250789Thermo Scientific Oxoid 阿茲特羅南/阿維巴坦盤 (30/20 µg) AZA50

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 K253105HardyDisk AST 萬古霉素 30µg (FDC30)Hardy Diagnostics K251879蘇洛培南SPM 2 µgLiofilchem

官方來源

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資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。