FDA.report

510(k) K242911

Device
Medconn Glycated Hemoglobin Test system
Applicant
Shanghai Medconn Medical Technology Co., Ltd.
510(k) number
K242911
Product code
PDJ
Decision
Substantially Equivalent (SESE)
Decision date
2025-06-20
Date received
2024-09-24
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

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K252749Medconn 8K Glycated Hemoglobin Test SystemShanghai Medconn Medical Technology Co., Ltd.2026-01-06
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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