K231679
- 510(k) number
- K231679
- Device name
- CONTOUR® PLUS BLUE Blood Glucose Monitoring System
- Applicant
- Ascensia Diabetes Care NY · US
- Product code
- NBW — System, Test, Blood Glucose, Over The Counter
- Decision date
- 2024-02-23
- Date received
- 2023-06-09
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Clinical Chemistry
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K231679.pdf
Official FDA record: K231679
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.