510(k) clearance
CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Glucose Monitoring System; CONTOUR® NEXT ONE Blood Glucose Monitoring System
- 510(k) number
- K260545
- Applicant
- Ascensia Diabetes Care
- Decision date
- Aug 27, 2026
- Date received
- Feb 18, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- NBW
- Device type
- System, Test, Blood Glucose, Over The Counter
- Device class
- Class II
- Regulation
- 21 CFR 862.1345
- Advisory committee
- Clinical Chemistry
- Statement or summary
- Summary
- Third party
- N
- Location
- Valhalla, NY, US