FDA.report

510(k) K252749

Device
Medconn 8K Glycated Hemoglobin Test System
Applicant
Shanghai Medconn Medical Technology Co., Ltd.
510(k) number
K252749
Product code
PDJ
Decision
Substantially Equivalent (SESE)
Decision date
2026-01-06
Date received
2025-08-29
Regulation
862.1373
Classification name
Hemoglobin A1c Test System
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Related Records

Applicant Contact

Contact
Judan Guan
Address
#1018 Weichang Rd. Shanyang Town, Jinshan District Shanghai CN 201508 201508

FDA Registration Numbers

Source Documents

510(k) summary PDF

Other 510(k) Records For Product Code PDJ

510(k)DeviceApplicantDecision date
K250073Tosoh Automated Glycohemoglobin Analyzer HLC-723GR01Tosoh Bioscience, Inc.2025-10-03
K242911Medconn Glycated Hemoglobin Test systemShanghai Medconn Medical Technology Co., Ltd.2025-06-20
K220999Hipro Glycosylated Hemoglobin (HbA1c) Test SystemShijiazhuang Hipro Biotechnology Co., Ltd.2024-09-12
K200904Tosoh Automated Glycohemoglobin Analyzer HLC-723G8Tosoh Bioscience, Inc.2021-08-05
K200256ADVIA Chemistry Enzymatic Hemoglobin Ale (Alc_E) AssaySiemens Healthcare Diagnostics, Inc.2021-07-02
K193053Tina-quant Hemoglobin A1cDx Gen.3Roche Diagnostics Operations (Rdo)2020-03-26
K182651HbA1c AdvancedBeckman Coulter Ireland, Inc.2019-01-16
K182988Afinion HbA1c Dx on Afinion 2Alere Technologies AS2018-11-29
K173909Dimension Hemoglobin A1c AssaySiemens Healthcare Diagnostics, Inc.2018-07-13
K173206SEKURE HbA1c AssaySekisui Diagnostics P.E.I., Inc.2018-07-12
K180296Afinion HbA1c DxAlere Technologies AS2018-05-07
K171861CAPILLARYS Hb A1cSebia2018-02-07
K171771ADVIA Chemistry Enzymatic Hemoglobin A1c (A1c_E) AssaySiemens Healthcare Diagnostics, Inc.2017-12-04
K171537CAPI 3 Hb A1cSebia2017-09-12
K162822ADAMS A1c HA-8180V, CALIBRATOR 80Arkray Factory, Inc.2017-06-29