FDA 510(k)

ETEST 普拉茲米辛（PLZ）（0.016-256 µg/mL）

K 號：K200512 · 2020-05-07

決定日期2020-05-07

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 Plazomicin (PLZ) (0.016-256 µg/mL) is the device name listed in this FDA 510(k) record. The listed applicant is Biomérieux SA. It received FDA 510(k) clearance on 2020-05-07 under 510(k) number K200512. 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 Plazomicin (PLZ) (0.016-256 µg/mL)?

ETEST Plazomicin (PLZ) (0.016-256 µg/mL) is a medical device that received FDA 510(k) clearance on 2020-05-07. The listed applicant is Biomérieux SA. The 510(k) number is K200512.

When did ETEST Plazomicin (PLZ) (0.016-256 µg/mL) receive FDA 510(k) clearance?

ETEST Plazomicin (PLZ) (0.016-256 µg/mL) received FDA 510(k) clearance on 2020-05-07, under 510(k) number K200512.

Who is the listed applicant for ETEST Plazomicin (PLZ) (0.016-256 µg/mL)?

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

What is the FDA product code for ETEST Plazomicin (PLZ) (0.016-256 µg/mL)?

The FDA product code for ETEST Plazomicin (PLZ) (0.016-256 µg/mL) is JWY.

其他以 Biomérieux SA 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。

K260447ETEST Gepotidacin (GEP) (0.016-256 µg/mL)K210793VIDAS 腎功能檢查

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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