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FDA 510(k)

川澄實驗室血液採集套件（BDK）系統

K 號：K172957 · 2018-09-28

申請人Kawasumi Laboratories, Inc.
決定日期2018-09-28
產品代碼KSB
諮詢委員會HE 請提供完整的描述文本，以便我能夠進行翻譯。
決定相當於

器材摘要

Kawasumi Laboratories Blood Drawing Kit (BDK) System is the device name listed in this FDA 510(k) record. The listed applicant is Kawasumi Laboratories, Inc.. It received FDA 510(k) clearance on 2018-09-28 under 510(k) number K172957. The device is classified under product code KSB. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Kawasumi Laboratories Blood Drawing Kit (BDK) System?

Kawasumi Laboratories Blood Drawing Kit (BDK) System is a medical device that received FDA 510(k) clearance on 2018-09-28. The listed applicant is Kawasumi Laboratories, Inc.. The 510(k) number is K172957.

When did Kawasumi Laboratories Blood Drawing Kit (BDK) System receive FDA 510(k) clearance?

Kawasumi Laboratories Blood Drawing Kit (BDK) System received FDA 510(k) clearance on 2018-09-28, under 510(k) number K172957.

Who is the listed applicant for Kawasumi Laboratories Blood Drawing Kit (BDK) System?

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

What is the FDA product code for Kawasumi Laboratories Blood Drawing Kit (BDK) System?

The FDA product code for Kawasumi Laboratories Blood Drawing Kit (BDK) System is KSB.

相關臨床試驗

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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其他以 Kawasumi Laboratories, 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。

K190485川澄多樣本適配器，配備預裝夾子（MBCH）K190233K-Shield 優勢 Port 接口輸液組 (PAIS)

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