FDA.report

510(k) K250073

Device
Tosoh Automated Glycohemoglobin Analyzer HLC-723GR01
Applicant
Tosoh Bioscience, Inc.
510(k) number
K250073
Product code
PDJ
Decision
Substantially Equivalent (SESE)
Decision date
2025-10-03
Date received
2025-01-10
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
Corike Nuibe
Address
3600 Gantz Rd. Grove City OH US 43123 43123

FDA Registration Numbers

Source Documents

510(k) summary PDF

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K173909Dimension Hemoglobin A1c AssaySiemens Healthcare Diagnostics, Inc.2018-07-13
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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