FDA 510(k)

Liofilchem MIC測試紙(MTS) - Dalbavancin於0.002 - 32 µg/ml

K 號：K153569 · 2016-06-22

決定日期2016-06-22

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

Liofilchem MIC Test Strip (MTS) -Dalbavancin at 0.002 - 32 ug/ml is the device name listed in this FDA 510(k) record. The listed applicant is Liofilchem s.r.l.. It received FDA 510(k) clearance on 2016-06-22 under 510(k) number K153569. 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 Liofilchem MIC Test Strip (MTS) -Dalbavancin at 0.002 - 32 ug/ml?

Liofilchem MIC Test Strip (MTS) -Dalbavancin at 0.002 - 32 ug/ml is a medical device that received FDA 510(k) clearance on 2016-06-22. The listed applicant is Liofilchem s.r.l.. The 510(k) number is K153569.

When did Liofilchem MIC Test Strip (MTS) -Dalbavancin at 0.002 - 32 ug/ml receive FDA 510(k) clearance?

Liofilchem MIC Test Strip (MTS) -Dalbavancin at 0.002 - 32 ug/ml received FDA 510(k) clearance on 2016-06-22, under 510(k) number K153569.

Who is the listed applicant for Liofilchem MIC Test Strip (MTS) -Dalbavancin at 0.002 - 32 ug/ml?

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

What is the FDA product code for Liofilchem MIC Test Strip (MTS) -Dalbavancin at 0.002 - 32 ug/ml?

The FDA product code for Liofilchem MIC Test Strip (MTS) -Dalbavancin at 0.002 - 32 ug/ml is JWY.

其他以 Liofilchem s.r.l. 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。

K260696MTS Gepotidacin 0.016-256 µg/mL K252114MTS 阿茲特羅南-阿維巴坦 0.016/4 - 256/4 µg/mL K251580MTS Sulbactam-Durlobactam 0.004/4 - 64/4 µg/mL (SUD)K243202MTS Ceftobiprole 0.002-32 µg/mL K230479ComASP 葡萄球菌素 0.008-128 K211672MTS 皮培拉星-他唑巴坦 0.016/4 - 256/4µg/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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