FDA 510(k)

塞福比普勒BPR 5 µg 盤

K 號：K250885 · 2025-06-23

決定日期2025-06-23

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

Ceftobiprole BPR 5 µg Disc is the device name listed in this FDA 510(k) record. The listed applicant is Liofilchem, Inc.. It received FDA 510(k) clearance on 2025-06-23 under 510(k) number K250885. 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 Ceftobiprole BPR 5 µg Disc?

Ceftobiprole BPR 5 µg Disc is a medical device that received FDA 510(k) clearance on 2025-06-23. The listed applicant is Liofilchem, Inc.. The 510(k) number is K250885.

When did Ceftobiprole BPR 5 µg Disc receive FDA 510(k) clearance?

Ceftobiprole BPR 5 µg Disc received FDA 510(k) clearance on 2025-06-23, under 510(k) number K250885.

Who is the listed applicant for Ceftobiprole BPR 5 µg Disc?

FDA 510(k)記錄將 Liofilchem, Inc. 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for Ceftobiprole BPR 5 µg Disc?

The FDA product code for Ceftobiprole BPR 5 µg Disc is JTN.

其他以 Liofilchem, Inc. 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。

K261853Gepotidacin GEP 10 µg

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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