FDA 510(k)

BD MiniDraw® 微量血採集系統搭配 BD MiniDraw® H&H 微量血採集管

K 號：K230493 · 2023-11-27

決定日期2023-11-27

產品代碼GIM

諮詢委員會CH

決定相當於

器材摘要

BD MiniDraw Capillary Blood Collection System with BD MiniDraw H&H Capillary Blood Collection Tube 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 2023-11-27 under 510(k) number K230493. The device is classified under product code GIM. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the BD MiniDraw Capillary Blood Collection System with BD MiniDraw H&H Capillary Blood Collection Tube?

BD MiniDraw Capillary Blood Collection System with BD MiniDraw H&H Capillary Blood Collection Tube is a medical device that received FDA 510(k) clearance on 2023-11-27. The listed applicant is Becton, Dickinson and Company. The 510(k) number is K230493.

When did BD MiniDraw Capillary Blood Collection System with BD MiniDraw H&H Capillary Blood Collection Tube receive FDA 510(k) clearance?

BD MiniDraw Capillary Blood Collection System with BD MiniDraw H&H Capillary Blood Collection Tube received FDA 510(k) clearance on 2023-11-27, under 510(k) number K230493.

Who is the listed applicant for BD MiniDraw Capillary Blood Collection System with BD MiniDraw H&H Capillary Blood Collection Tube?

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 MiniDraw Capillary Blood Collection System with BD MiniDraw H&H Capillary Blood Collection Tube?

The FDA product code for BD MiniDraw Capillary Blood Collection System with BD MiniDraw H&H Capillary Blood Collection Tube is GIM.

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：GIM）

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。

K240455BD Vacutainer® Citrate 血液採集管Becton, Dickinson and Company K213670BD Vacutainer K2EDTA 血液採集管, BD Vacutainer K3EDTA 血液採集管Becton, Dickinson and Company K162723TransFix/EDTA 真空血液採集管Caltag Medsystems, Ltd.

官方來源

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