When did VITEK 2 AST-Gram Negative Cefazolin (= 32 µg/mL) receive FDA 510(k) clearance?

VITEK 2 AST-Gram Negative Cefazolin (= 32 µg/mL) received FDA 510(k) clearance on 2025-08-21, under 510(k) number K251579.

FDA 510(k)

VITEK 2 AST-革蘭氏陰性細菌頭孢噻呋（=<1-=>32 µg/mL）

K 號：K251579 · 2025-08-21

申請人bioMerieux, Inc.

決定日期2025-08-21

產品代碼LON

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

VITEK 2 AST-Gram Negative Cefazolin (=<1-=>32 µg/mL) is the device name listed in this FDA 510(k) record. The listed applicant is bioMerieux, Inc.. It received FDA 510(k) clearance on 2025-08-21 under 510(k) number K251579. 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 Negative Cefazolin (=<1-=>32 µg/mL)?

VITEK 2 AST-Gram Negative Cefazolin (=<1-=>32 µg/mL) is a medical device that received FDA 510(k) clearance on 2025-08-21. The listed applicant is bioMerieux, Inc.. The 510(k) number is K251579.

When did VITEK 2 AST-Gram Negative Cefazolin (=<1-=>32 µg/mL) receive FDA 510(k) clearance?

VITEK 2 AST-Gram Negative Cefazolin (=<1-=>32 µg/mL) received FDA 510(k) clearance on 2025-08-21, under 510(k) number K251579.

Who is the listed applicant for VITEK 2 AST-Gram Negative Cefazolin (=<1-=>32 µg/mL)?

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

What is the FDA product code for VITEK 2 AST-Gram Negative Cefazolin (=<1-=>32 µg/mL)?

The FDA product code for VITEK 2 AST-Gram Negative Cefazolin (=<1-=>32 µg/mL) is LON.

其他以 bioMerieux, Inc. 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。

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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。

K260282VITEK 2 AST-引起性青銅色球菌克林達霉素抗藥性bioMerieux, Inc.K260281VITEK 2 AST-草黃桉桿酸鹽（<=0.125 - >=8 µg/mL）BIOMERIEUX K251713BD Phoenix自動微生物學系統 - GN Eravacycline (0.125-2 µg/mL)Becton, Dickinson and Company K250447BD Phoenix™自動微生物學系統 - GN Imipenem-relebactam (0.0625/4 - 16/4 µg/mL)Becton, Dickinson and Company K234012VITEK 精簡型 PRObioMerieux, Inc.K250344BD Phoenix™自動微生物學系統Becton, Dickinson and Company

官方來源

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