FDA 510(k)

HemoScreen 體液分析儀

K 號：K180020 · 2018-10-29

決定日期2018-10-29

產品代碼GKZ

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

HemoScreen Hematology Analyzer is the device name listed in this FDA 510(k) record. The listed applicant is Pixcell Medical Technologies, Ltd.. It received FDA 510(k) clearance on 2018-10-29 under 510(k) number K180020. The device is classified under product code GKZ. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the HemoScreen Hematology Analyzer?

HemoScreen Hematology Analyzer is a medical device that received FDA 510(k) clearance on 2018-10-29. The listed applicant is Pixcell Medical Technologies, Ltd.. The 510(k) number is K180020.

When did HemoScreen Hematology Analyzer receive FDA 510(k) clearance?

HemoScreen Hematology Analyzer received FDA 510(k) clearance on 2018-10-29, under 510(k) number K180020.

Who is the listed applicant for HemoScreen Hematology Analyzer?

The FDA 510(k) record lists Pixcell Medical Technologies, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HemoScreen Hematology Analyzer?

The FDA product code for HemoScreen Hematology Analyzer is GKZ.

其他以 Pixcell Medical Technologies, Ltd. 為申請人之記錄

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K222148HemoScreen 體液分析儀

相關器械（代碼：GKZ）

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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