Cleared Traditional

Tosoh Automated Glycohemoglobin Analyzer HLC-723G8

K200904 · Tosoh Bioscience, Inc. · Chemistry

Aug 2021

Decision

486d

Days

Class 2

Risk

About This 510(k) Submission

K200904 is an FDA 510(k) clearance for the Tosoh Automated Glycohemoglobin Analyzer HLC-723G8, a Hemoglobin A1c Test System (Class II — Special Controls, product code PDJ), submitted by Tosoh Bioscience, Inc. (South San Franciso, US). The FDA issued a Cleared decision on August 5, 2021, 486 days after receiving the submission on April 6, 2020. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1373.

Submission Details

510(k) Number	K200904 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 06, 2020
Decision Date	August 05, 2021
Days to Decision	486 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.