FDA 510(k)

ETEST® Sulbactam/Durlobactam (SUD) (0.004/4-64/4 µg/mL)，ETEST® SUD

K 號：K232395 · 2023-10-05

決定日期2023-10-05

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

ETEST® Sulbactam/Durlobactam (SUD) (0.004/4-64/4 µg/mL), ETEST® SUD is the device name listed in this FDA 510(k) record. The listed applicant is Biomérieux. It received FDA 510(k) clearance on 2023-10-05 under 510(k) number K232395. 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® Sulbactam/Durlobactam (SUD) (0.004/4-64/4 µg/mL), ETEST® SUD?

ETEST® Sulbactam/Durlobactam (SUD) (0.004/4-64/4 µg/mL), ETEST® SUD is a medical device that received FDA 510(k) clearance on 2023-10-05. The listed applicant is Biomérieux. The 510(k) number is K232395.

When did ETEST® Sulbactam/Durlobactam (SUD) (0.004/4-64/4 µg/mL), ETEST® SUD receive FDA 510(k) clearance?

ETEST® Sulbactam/Durlobactam (SUD) (0.004/4-64/4 µg/mL), ETEST® SUD received FDA 510(k) clearance on 2023-10-05, under 510(k) number K232395.

Who is the listed applicant for ETEST® Sulbactam/Durlobactam (SUD) (0.004/4-64/4 µg/mL), ETEST® SUD?

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

What is the FDA product code for ETEST® Sulbactam/Durlobactam (SUD) (0.004/4-64/4 µg/mL), ETEST® SUD?

The FDA product code for ETEST® Sulbactam/Durlobactam (SUD) (0.004/4-64/4 µg/mL), ETEST® SUD is JWY.

其他以 Biomérieux 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。

K250856ETEST 阿茲特羅南/阿維巴坦 (AZA) (0.016/4-256/4 µg/mL)

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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