FDA 510(k)

BC-5D 血液學控制儀

K 號：K160606 · 2016-09-01

決定日期2016-09-01

產品代碼JPK

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

BC-5D Hematology Control is the device name listed in this FDA 510(k) record. The listed applicant is R&D Systems, Inc.. It received FDA 510(k) clearance on 2016-09-01 under 510(k) number K160606. The device is classified under product code JPK. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the BC-5D Hematology Control?

BC-5D Hematology Control is a medical device that received FDA 510(k) clearance on 2016-09-01. The listed applicant is R&D Systems, Inc.. The 510(k) number is K160606.

When did BC-5D Hematology Control receive FDA 510(k) clearance?

BC-5D Hematology Control received FDA 510(k) clearance on 2016-09-01, under 510(k) number K160606.

Who is the listed applicant for BC-5D Hematology Control?

The FDA 510(k) record lists R&D Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BC-5D Hematology Control?

The FDA product code for BC-5D Hematology Control is JPK.

相關器械（代碼：JPK）

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器材摘要

常見問題

相關臨床試驗

相關器械（代碼：JPK）

官方來源