FDA 510(k)

ETEST 該藥物名稱 (DFX) (0.002-32 µg/mL)

K 號：K192738 · 2019-11-26

決定日期2019-11-26

產品代碼JWY

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

ETEST Delafloxacin (DFX) (0.002-32 µg/mL) is the device name listed in this FDA 510(k) record. The listed applicant is Biomerieux S.A.. It received FDA 510(k) clearance on 2019-11-26 under 510(k) number K192738. The device is classified under product code JWY. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the ETEST Delafloxacin (DFX) (0.002-32 µg/mL)?

ETEST Delafloxacin (DFX) (0.002-32 µg/mL) is a medical device that received FDA 510(k) clearance on 2019-11-26. The listed applicant is Biomerieux S.A.. The 510(k) number is K192738.

When did ETEST Delafloxacin (DFX) (0.002-32 µg/mL) receive FDA 510(k) clearance?

ETEST Delafloxacin (DFX) (0.002-32 µg/mL) received FDA 510(k) clearance on 2019-11-26, under 510(k) number K192738.

Who is the listed applicant for ETEST Delafloxacin (DFX) (0.002-32 µg/mL)?

The FDA 510(k) record lists Biomerieux S.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ETEST Delafloxacin (DFX) (0.002-32 µg/mL)?

The FDA product code for ETEST Delafloxacin (DFX) (0.002-32 µg/mL) is JWY.

其他以 Biomerieux S.A. 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。

K250274ETEST 胺苄西林/雷萊巴坦對黃金黴菌（P. aeruginosa）（IRPA）（0.008/4-128/4 µg/mL）K210757ETEST 磷霉素 (FO) (0.032-512 µg/mL)K192050ETEST 埃拉瓦西林（ERV）(0.002 – 32 µg/mL)K191953ETEST 奧美拉膽素/雷萊巴坦 (IPR) (0.002/4-32/4 微克/毫升)K190154ETEST 皮培拉星/他唑巴坦 (P/T) (0.016/4-256/4 微克/毫升)K183031ETEST美洛培南/沃巴卡坦（MEV）（0.004/8-64/8 µg/mL）

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相關器械（代碼：JWY）

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。

K260447ETEST Gepotidacin (GEP) (0.016-256 µg/mL)bioMérieux SA K260696MTS Gepotidacin 0.016-256 µg/mLLiofilchem s.r.l.K252114MTS 阿茲特羅南-阿維巴坦 0.016/4 - 256/4 µg/mLLiofilchem s.r.l.K252062The Sensititre 18-24 小時 MIC 或斷點敏感度系統，含聚糖素於 0.12-16 µg/mL 稀釋範圍內Thermo Fisher Scientific K250575Sensititre 18-24小時MIC或斷點敏感度系統，含阿茲特羅胺/阿維巴坦，濃度範圍為0.008/4 - 64/4 µg/mLThermo Fisher Scientific K252014Sensititre 18-24小時MIC或斷點敏感度系統，含阿米卡星，濃度範圍為0.25-256 µg/mLThermo Fisher Scientific

官方來源

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