FDA 510(k)

Minuteful-kidney 試驗

K 號：K222921 · 2023-09-08

決定日期2023-09-08

產品代碼JIR

諮詢委員會CH

決定相當於

器材摘要

Minuteful-kidney test is the device name listed in this FDA 510(k) record. The listed applicant is Healthy.Io, Ltd.. It received FDA 510(k) clearance on 2023-09-08 under 510(k) number K222921. The device is classified under product code JIR. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Minuteful-kidney test?

Minuteful-kidney test is a medical device that received FDA 510(k) clearance on 2023-09-08. The listed applicant is Healthy.Io, Ltd.. The 510(k) number is K222921.

When did Minuteful-kidney test receive FDA 510(k) clearance?

Minuteful-kidney test received FDA 510(k) clearance on 2023-09-08, under 510(k) number K222921.

Who is the listed applicant for Minuteful-kidney test?

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

What is the FDA product code for Minuteful-kidney test?

The FDA product code for Minuteful-kidney test is JIR.

其他以 Healthy.Io, Ltd. 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。

K210069Minuteful - 腎臟檢測 K182384ACR LAB 尿液分析測試系統 K173327DIP/美國尿檢分析測試系統

相關器械（代碼：JIR）

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。

K210069Minuteful - 腎臟檢測Healthy.Io, Ltd.

官方來源

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