Medconn 8K Glycated Hemoglobin Test System— 510(k) K252749

Name: FDA 510(k) clearance K252749
Creator: U.S. Food and Drug Administration
Published: 2026-01-06

Substantially Equivalent

Shanghai Medconn Medical Technology Co., Ltd.

FDA 510(k) clearance K252749 for Medconn 8K Glycated Hemoglobin Test System, Substantially Equivalent on 2026-01-06. Applicant: Shanghai Medconn Medical Technology Co., Ltd.. Device class: 2.

Clearance details

Applicant: Shanghai Medconn Medical Technology Co., Ltd.
Product code: Code PDJ
Device class: Class 2
Regulation: 21 CFR 862.1373
Advisory panel: Clinical Chemistry
Date received: 2025-08-29
Decision date: 2026-01-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shanghai, CN

Download summary PDF View on FDA.gov ↗

Recent devices under product code PDJ

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K250073 — Tosoh Automated Glycohemoglobin Analyzer HLC-723GR012025-10-03
K242911 — Medconn Glycated Hemoglobin Test system2025-06-20
K220999 — Hipro Glycosylated Hemoglobin (HbA1c) Test System2024-09-12
K200904 — Tosoh Automated Glycohemoglobin Analyzer HLC-723G82021-08-05
K200256 — ADVIA Chemistry Enzymatic Hemoglobin Ale (Alc_E) Assay2021-07-02

Data sourced from openFDA. This site is unofficial and independent of the FDA.