FDA 510(k)

Athelas Home

K 號：K200828 · 2022-03-22

決定日期2022-03-22

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

Athelas Home is the device name listed in this FDA 510(k) record. The listed applicant is Athelas, Inc.. It received FDA 510(k) clearance on 2022-03-22 under 510(k) number K200828. 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 Athelas Home?

Athelas Home is a medical device that received FDA 510(k) clearance on 2022-03-22. The listed applicant is Athelas, Inc.. The 510(k) number is K200828.

When did Athelas Home receive FDA 510(k) clearance?

Athelas Home received FDA 510(k) clearance on 2022-03-22, under 510(k) number K200828.

Who is the listed applicant for Athelas Home?

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

What is the FDA product code for Athelas Home?

The FDA product code for Athelas Home is GKZ.

其他以 Athelas, 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。

K243348Athelas Home K181288Athelas One

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。

K260781裕米森 H550HORIBA ABX SAS K253212XR系列（XR-10，XR-20）自動血液學分析儀Sysmex America, Inc.K243348Athelas HomeAthelas, Inc.K251249真血學檢測Truvian Sciences, Inc.K251371Sysmex XR系列（XR-20）自動血液學分析儀Sysmex America, Inc.K250943Sysmex XR系列（XR-10）自動血液學分析儀Sysmex America, Inc.

官方來源

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