FDA 510(k)

Medconn 8K 糖化血紅蛋白檢測系統

K 號：K252749 · 2026-01-06

申請人Shanghai Medconn Medical Technology Co., Ltd.

決定日期2026-01-06

產品代碼PDJ

諮詢委員會CH

決定相當於

器材摘要

Medconn 8K Glycated Hemoglobin Test System is the device name listed in this FDA 510(k) record. The listed applicant is Shanghai Medconn Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2026-01-06 under 510(k) number K252749. The device is classified under product code PDJ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Medconn 8K Glycated Hemoglobin Test System?

Medconn 8K Glycated Hemoglobin Test System is a medical device that received FDA 510(k) clearance on 2026-01-06. The listed applicant is Shanghai Medconn Medical Technology Co., Ltd.. The 510(k) number is K252749.

When did Medconn 8K Glycated Hemoglobin Test System receive FDA 510(k) clearance?

Medconn 8K Glycated Hemoglobin Test System received FDA 510(k) clearance on 2026-01-06, under 510(k) number K252749.

Who is the listed applicant for Medconn 8K Glycated Hemoglobin Test System?

The FDA 510(k) record lists Shanghai Medconn Medical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Medconn 8K Glycated Hemoglobin Test System?

The FDA product code for Medconn 8K Glycated Hemoglobin Test System is PDJ.

其他以 Shanghai Medconn Medical Technology Co., 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。

K242911Medconn 糖化血紅蛋白測試系統

相關器械（代碼：PDJ）

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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