FDA 510(k)

BD Phoenix™自動微生物學系統

K 號：K250344 · 2025-03-06

決定日期2025-03-06

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

BD Phoenix™ Automated Microbiology System is the device name listed in this FDA 510(k) record. The listed applicant is Becton, Dickinson and Company. It received FDA 510(k) clearance on 2025-03-06 under 510(k) number K250344. 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 BD Phoenix™ Automated Microbiology System?

BD Phoenix™ Automated Microbiology System is a medical device that received FDA 510(k) clearance on 2025-03-06. The listed applicant is Becton, Dickinson and Company. The 510(k) number is K250344.

When did BD Phoenix™ Automated Microbiology System receive FDA 510(k) clearance?

BD Phoenix™ Automated Microbiology System received FDA 510(k) clearance on 2025-03-06, under 510(k) number K250344.

Who is the listed applicant for BD Phoenix™ Automated Microbiology System?

The FDA 510(k) record lists Becton, Dickinson and Company as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BD Phoenix™ Automated Microbiology System?

The FDA product code for BD Phoenix™ Automated Microbiology System is LON.

其他以 Becton, Dickinson and Company 為申請人之記錄

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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 K234012VITEK 精簡型 PRObioMerieux, Inc.

官方來源

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