FDA 510(k)

BD Vacutainer® 多樣本 Luer 适配器

K 號：K243649 · 2025-03-21

決定日期2025-03-21

產品代碼JKA

諮詢委員會CH

決定相當於

器材摘要

BD Vacutainer® Multiple Sample Luer Adapter 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 2025-03-21 under 510(k) number K243649. The device is classified under product code JKA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the BD Vacutainer® Multiple Sample Luer Adapter?

BD Vacutainer® Multiple Sample Luer Adapter is a medical device that received FDA 510(k) clearance on 2025-03-21. The listed applicant is Becton, Dickinson and Company. The 510(k) number is K243649.

When did BD Vacutainer® Multiple Sample Luer Adapter receive FDA 510(k) clearance?

BD Vacutainer® Multiple Sample Luer Adapter received FDA 510(k) clearance on 2025-03-21, under 510(k) number K243649.

Who is the listed applicant for BD Vacutainer® Multiple Sample Luer Adapter?

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 Vacutainer® Multiple Sample Luer Adapter?

The FDA product code for BD Vacutainer® Multiple Sample Luer Adapter is JKA.

其他以 Becton, Dickinson and Company 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。

K262163BD BBL穆勒-金頓II培養基（陽離子調整）；BD Difco穆勒-金頓培養基 K260128BD Preset™ 和 BD A-Line™ 动脈血液採集針筒 K252506BD Vacutainer® 安全鎖™ 採血套組; BD Vacutainer® 安全鎖™ 採血套組配預裝持桿器 K252378BD® MiniDraw™ 微量血採集系統配BD® MiniDraw™ SST™ 微量血採集管 K260184Onclarity™ 自取樣套件 K252040BD Vacutainer® 血漿分離管 (PST™), BD Vacutainer® 钠鹽肝素採血管

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相關器械（代碼：JKA）

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。

K262215Profoject™ 安全滑動血液收集套組CMT Health PTE., Ltd.K252899女性培養設備；男性培養設備；傳送設備；進入設備Zhejiang Kindly Medical Device Co., Ltd.K260128BD Preset™ 和 BD A-Line™ 动脈血液採集針筒Becton, Dickinson and Company K252506BD Vacutainer® 安全鎖™ 採血套組; BD Vacutainer® 安全鎖™ 採血套組配預裝持桿器Becton, Dickinson and Company K252378BD® MiniDraw™ 微量血採集系統配BD® MiniDraw™ SST™ 微量血採集管Becton, Dickinson and Company K252040BD Vacutainer® 血漿分離管 (PST™), BD Vacutainer® 钠鹽肝素採血管Becton, Dickinson and Company

官方來源

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