VITEK 2 AST-陽性細菌線唑醇（<=0.5 – >=8 µg/mL）
K 號：K212849 · 2022-02-04
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器材摘要
VITEK 2 AST-Gram Positive Linezolid (<=0.5 – >=8 µg/mL) is the device name listed in this FDA 510(k) record. The listed applicant is Biomérieux, Inc.. It received FDA 510(k) clearance on 2022-02-04 under 510(k) number K212849. The device is classified under product code LON. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the VITEK 2 AST-Gram Positive Linezolid (<=0.5 – >=8 µg/mL)?
VITEK 2 AST-Gram Positive Linezolid (<=0.5 – >=8 µg/mL) is a medical device that received FDA 510(k) clearance on 2022-02-04. The listed applicant is Biomérieux, Inc.. The 510(k) number is K212849.
When did VITEK 2 AST-Gram Positive Linezolid (<=0.5 – >=8 µg/mL) receive FDA 510(k) clearance?
VITEK 2 AST-Gram Positive Linezolid (<=0.5 – >=8 µg/mL) received FDA 510(k) clearance on 2022-02-04, under 510(k) number K212849.
Who is the listed applicant for VITEK 2 AST-Gram Positive Linezolid (<=0.5 – >=8 µg/mL)?
The FDA 510(k) record lists Biomérieux, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for VITEK 2 AST-Gram Positive Linezolid (<=0.5 – >=8 µg/mL)?
The FDA product code for VITEK 2 AST-Gram Positive Linezolid (<=0.5 – >=8 µg/mL) is LON.
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。
相關器械（代碼：LON）
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。
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官方來源
在 FDA 資料庫中查看 →資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。
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