K260545
- 510(k) number
- K260545
- Device name
- CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Glucose Monitoring System; CONTOUR® NEXT ONE Blood Glucose Monitoring System
- Applicant
- Ascensia Diabetes Care NY · US
- Product code
- NBW — System, Test, Blood Glucose, Over The Counter
- Decision date
- 2026-08-27
- Date received
- 2026-02-18
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Clinical Chemistry
PDFDownload 510(k) SummaryArchived here · 1.8 MB · U.S. public domain
Also available from FDA: K260545.pdf
Official FDA record: K260545
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.