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FDA 510(k)

Sensititre 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/mL

K 號：K250575 · 2025-09-05

申請人Thermo Fisher Scientific
決定日期2025-09-05
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

The Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System with Aztreonam/avibactam in the dilution range of 0.008/4 - 64/4 ug/mL is the device name listed in this FDA 510(k) record. The listed applicant is Thermo Fisher Scientific. It received FDA 510(k) clearance on 2025-09-05 under 510(k) number K250575. 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 The Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System with Aztreonam/avibactam in the dilution range of 0.008/4 - 64/4 ug/mL?

The Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System with Aztreonam/avibactam in the dilution range of 0.008/4 - 64/4 ug/mL is a medical device that received FDA 510(k) clearance on 2025-09-05. The listed applicant is Thermo Fisher Scientific. The 510(k) number is K250575.

When did The Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System with Aztreonam/avibactam in the dilution range of 0.008/4 - 64/4 ug/mL receive FDA 510(k) clearance?

The Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System with Aztreonam/avibactam in the dilution range of 0.008/4 - 64/4 ug/mL received FDA 510(k) clearance on 2025-09-05, under 510(k) number K250575.

Who is the listed applicant for The Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System with Aztreonam/avibactam in the dilution range of 0.008/4 - 64/4 ug/mL?

The FDA 510(k) record lists Thermo Fisher Scientific as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for The Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System with Aztreonam/avibactam in the dilution range of 0.008/4 - 64/4 ug/mL?

The FDA product code for The Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System with Aztreonam/avibactam in the dilution range of 0.008/4 - 64/4 ug/mL is JWY.

相關臨床試驗

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。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

其他以 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。

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/mLK250990Sensititre 18-24小時MIC或斷點敏感度系統，含Ciprofloxacin於0.002-64 µg/mL的稀釋範圍內K242843Sensititre 20-24小時流感嗜血桿菌/肺炎鏈球菌（HP）MIC或斷點敏感度系統，含Ceftobiprole於0.008-16 µg/mL濃度範圍內。K242659Sensititre 18-24小時MIC或斷點敏感度系統，含去甲氧西林，濃度範圍為0.25-128 µg/mLK242658Sensititre 18-24小時MIC或斷點敏感度系統，含莫西沙星，濃度範圍為0.008-16 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 SAK260696MTS 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 ScientificK252014Sensititre 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 ScientificK251580MTS Sulbactam-Durlobactam 0.004/4 - 64/4 µg/mL (SUD)Liofilchem s.r.l.

官方來源

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