K231465
- 510(k) number
- K231465
- Device name
- Q-Pad Test System
- Applicant
- Qurasense CA · US
- Product code
- LCP — Assay, Glycosylated Hemoglobin
- Decision date
- 2023-12-06
- Date received
- 2023-05-19
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Hematology
PDFDownload 510(k) SummaryArchived here · 2.8 MB · U.S. public domain
Also available from FDA: K231465.pdf
Official FDA record: K231465
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.