Cleared Traditional

Tosoh Automated Glycohemoglobin Analyzer HLC-723GR01

K250073 · Tosoh Bioscience, Inc. · Chemistry

Oct 2025

Decision

266d

Days

Class 2

Risk

About This 510(k) Submission

K250073 is an FDA 510(k) clearance for the Tosoh Automated Glycohemoglobin Analyzer HLC-723GR01, a Hemoglobin A1c Test System (Class II — Special Controls, product code PDJ), submitted by Tosoh Bioscience, Inc. (Grove City, US). The FDA issued a Cleared decision on October 3, 2025, 266 days after receiving the submission on January 10, 2025. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1373.

Submission Details

510(k) Number	K250073 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 10, 2025
Decision Date	October 03, 2025
Days to Decision	266 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Summary PDF

Device Classification

Product Code	PDJ — Hemoglobin A1c Test System
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 862.1373
Definition	Quantitative Determination Of Hemoglobin A1c To Aid In The Diagnosis Of Diabetes.