K250073
- 510(k) number
- K250073
- Device name
- Tosoh Automated Glycohemoglobin Analyzer HLC-723GR01
- Applicant
- Tosoh Bioscience, Inc. OH · US
- Product code
- PDJ — Hemoglobin A1c Test System
- Decision date
- 2025-10-03
- Date received
- 2025-01-10
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Clinical Chemistry
PDFDownload 510(k) SummaryArchived here · 0.8 MB · U.S. public domain
Also available from FDA: K250073.pdf
Official FDA record: K250073
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.