FDA 510(k)

Unicel DxH 800 考特細胞分析系統

K 號：K193124 · 2020-04-16

決定日期2020-04-16

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

Unicel DxH 800 Coulter Cellular Analysis System is the device name listed in this FDA 510(k) record. The listed applicant is Beckman Coulter. It received FDA 510(k) clearance on 2020-04-16 under 510(k) number K193124. 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 Unicel DxH 800 Coulter Cellular Analysis System?

Unicel DxH 800 Coulter Cellular Analysis System is a medical device that received FDA 510(k) clearance on 2020-04-16. The listed applicant is Beckman Coulter. The 510(k) number is K193124.

When did Unicel DxH 800 Coulter Cellular Analysis System receive FDA 510(k) clearance?

Unicel DxH 800 Coulter Cellular Analysis System received FDA 510(k) clearance on 2020-04-16, under 510(k) number K193124.

Who is the listed applicant for Unicel DxH 800 Coulter Cellular Analysis System?

The FDA 510(k) record lists Beckman Coulter as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Unicel DxH 800 Coulter Cellular Analysis System?

The FDA product code for Unicel DxH 800 Coulter Cellular Analysis System is GKZ.

其他以 Beckman Coulter 為申請人之記錄

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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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