FDA 510(k)

川澄多樣本適配器，配備預裝夾子（MBCH）

K 號：K190485 · 2019-07-08

決定日期2019-07-08

產品代碼JKA

諮詢委員會CH

決定相當於

器材摘要

Kawasumi Multiple Sample Adapter with Pre-Attached Holder (MBCH) 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 2019-07-08 under 510(k) number K190485. 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 Kawasumi Multiple Sample Adapter with Pre-Attached Holder (MBCH)?

Kawasumi Multiple Sample Adapter with Pre-Attached Holder (MBCH) is a medical device that received FDA 510(k) clearance on 2019-07-08. The listed applicant is Kawasumi Laboratories, Inc.. The 510(k) number is K190485.

When did Kawasumi Multiple Sample Adapter with Pre-Attached Holder (MBCH) receive FDA 510(k) clearance?

Kawasumi Multiple Sample Adapter with Pre-Attached Holder (MBCH) received FDA 510(k) clearance on 2019-07-08, under 510(k) number K190485.

Who is the listed applicant for Kawasumi Multiple Sample Adapter with Pre-Attached Holder (MBCH)?

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 Multiple Sample Adapter with Pre-Attached Holder (MBCH)?

The FDA product code for Kawasumi Multiple Sample Adapter with Pre-Attached Holder (MBCH) is JKA.

其他以 Kawasumi Laboratories, Inc. 為申請人之記錄

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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。

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官方來源

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