K252749
- 510(k) number
- K252749
- Device name
- Medconn 8K Glycated Hemoglobin Test System
- Applicant
- Shanghai Medconn Medical Technology Co., Ltd. CN
- Product code
- PDJ — Hemoglobin A1c Test System
- Decision date
- 2026-01-06
- Date received
- 2025-08-29
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Clinical Chemistry
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K252749.pdf
Official FDA record: K252749
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.