Members中文

PDJ

Hemoglobin A1c Test System

Product code
PDJ
Device name
Hemoglobin A1c Test System
Device class
Class 2
21 CFR
21 CFR 862.1373
Medical specialty
Clinical Chemistry
Marketing pathway
510(K)
510(k) clearances (last 3 years)
4
Summaries archived here
4 (direct download)
510(k) clearances (all years, FDA)
26 (all years; only the last 3 years are listed here)

FDA classification definition

Quantitative determination of Hemoglobin A1c to aid in the diagnosis of diabetes.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (4)

Last three years. Most recent: 2026-01-06.

NumberDecision dateApplicantDevice nameSummary
K2527492026-01-06Shanghai Medconn Medical Technology CoMedconn 8K Glycated Hemoglobin Test SystemPDF
K2500732025-10-03Tosoh Bioscience, Inc.Tosoh Automated Glycohemoglobin Analyzer HLC-723GR01PDF
K2429112025-06-20Shanghai Medconn Medical Technology CoMedconn Glycated Hemoglobin Test systemPDF
K2209992024-09-12Shijiazhuang Hipro Biotechnology Co., Hipro Glycosylated Hemoglobin (HbA1c) Test SystemPDF

4 summaries are archived here for direct download.

Official FDA classification page: PDJ
Classification and pathway per current FDA publications. Data from openFDA (CC0).