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510(k) K250073

Tosoh Automated Glycohemoglobin Analyzer HLC-723GR01 by Tosoh Bioscience, Inc. — Product Code PDJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 3, 2025
Date Received
January 10, 2025
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.

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  • K143296 — AIA-PACK C-Peptide Control Set (December 16, 2014)
  • K143144 — ST AIA-PACK PROG II Calibrator Set (December 3, 2014)
  • K140648 — ST AIA-PACK C-PEPTIDE II CALIBRATOR SET (April 10, 2014)
  • K131580 — AUTOMATED GYLCOHEMOGLOBIN ANALYZER HLC-723G8 (January 23, 2014)

Other clearances for product code PDJ

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  • 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)