FDA 510(k)

VITEK 精簡型 PRO

K 號：K234012 · 2025-03-14

決定日期2025-03-14

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 COMPACT PRO is the device name listed in this FDA 510(k) record. The listed applicant is bioMerieux, Inc.. It received FDA 510(k) clearance on 2025-03-14 under 510(k) number K234012. 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 COMPACT PRO?

VITEK COMPACT PRO is a medical device that received FDA 510(k) clearance on 2025-03-14. The listed applicant is bioMerieux, Inc.. The 510(k) number is K234012.

When did VITEK COMPACT PRO receive FDA 510(k) clearance?

VITEK COMPACT PRO received FDA 510(k) clearance on 2025-03-14, under 510(k) number K234012.

Who is the listed applicant for VITEK COMPACT PRO?

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 COMPACT PRO?

The FDA product code for VITEK COMPACT PRO 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。

K260160VITEK REVEAL GN AST 測試與VITEK REVEAL AST 系統 K260282VITEK 2 AST-引起性青銅色球菌克林達霉素抗藥性 K251579VITEK 2 AST-革蘭氏陰性細菌頭孢噻呋（=<1-=>32 µg/mL）K232967VITEK 2 AST-酵母伏立康唑（<= 0.03125 - >= 4 µg/mL）K232963VITEK 2 AST-酵母阿尼霉素（<= 0.015 - >= 8 µg/mL）K240279VIDAS TBI (GFAP, UCH-L1)

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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 K251579VITEK 2 AST-革蘭氏陰性細菌頭孢噻呋（=<1-=>32 µg/mL）bioMerieux, Inc.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 K250344BD Phoenix™自動微生物學系統Becton, Dickinson and Company

官方來源

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