Cleared Traditional

Medconn 8K Glycated Hemoglobin Test System

K252749 · Shanghai Medconn Medical Technology Co., Ltd. · Chemistry

Jan 2026

Decision

130d

Days

Class 2

Risk

About This 510(k) Submission

K252749 is an FDA 510(k) clearance for the Medconn 8K Glycated Hemoglobin Test System, a Hemoglobin A1c Test System (Class II — Special Controls, product code PDJ), submitted by Shanghai Medconn Medical Technology Co., Ltd. (Shanghai, CN). The FDA issued a Cleared decision on January 6, 2026, 130 days after receiving the submission on August 29, 2025. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1373.

Submission Details

510(k) Number	K252749 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 29, 2025
Decision Date	January 06, 2026
Days to Decision	130 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Summary PDF

Device Classification

Product Code	PDJ — Hemoglobin A1c Test System
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 862.1373
Definition	Quantitative Determination Of Hemoglobin A1c To Aid In The Diagnosis Of Diabetes.