Cleared Traditional

Medconn Glycated Hemoglobin Test system

K242911 · Shanghai Medconn Medical Technology Co., Ltd. · Chemistry

Jun 2025

Decision

269d

Days

Class 2

Risk

About This 510(k) Submission

K242911 is an FDA 510(k) clearance for the Medconn 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 June 20, 2025, 269 days after receiving the submission on September 24, 2024. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1373.

Submission Details

510(k) Number	K242911 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 24, 2024
Decision Date	June 20, 2025
Days to Decision	269 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.