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510(k) K242911

Medconn Glycated Hemoglobin Test system by Shanghai Medconn Medical Technology Co., Ltd. — Product Code PDJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 20, 2025
Date Received
September 24, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Hemoglobin A1c Test System
Device Class
Class II
Regulation Number
862.1373
Review Panel
CH
Submission Type

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

Other clearances by Shanghai Medconn Medical Technology Co., Ltd.

  • K252749 — Medconn 8K Glycated Hemoglobin Test System (January 6, 2026)

Other clearances for product code PDJ

  • K252749 — Medconn 8K Glycated Hemoglobin Test System (January 6, 2026)
  • K250073 — Tosoh Automated Glycohemoglobin Analyzer HLC-723GR01 (October 3, 2025)
  • K220999 — Hipro Glycosylated Hemoglobin (HbA1c) Test System (September 12, 2024)
  • K200904 — Tosoh Automated Glycohemoglobin Analyzer HLC-723G8 (August 5, 2021)
  • K200256 — ADVIA Chemistry Enzymatic Hemoglobin Ale (Alc_E) Assay (July 2, 2021)
  • K193053 — Tina-quant Hemoglobin A1cDx Gen.3 (March 26, 2020)
  • K182651 — HbA1c Advanced (January 16, 2019)
  • K182988 — Afinion HbA1c Dx on Afinion 2 (November 29, 2018)
  • K173909 — Dimension Hemoglobin A1c Assay (July 13, 2018)
  • K173206 — SEKURE HbA1c Assay (July 12, 2018)