K241787
- 510(k) number
- K241787
- Device name
- CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Glucose Monitoring System
- Applicant
- Ascensia Diabetes Care U.S., Inc. NJ · US
- Product code
- NBW — System, Test, Blood Glucose, Over The Counter
- Decision date
- 2024-08-27
- Date received
- 2024-06-21
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Clinical Chemistry
510(k) Summary (official FDA PDF): K241787.pdf
Official FDA record: K241787
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.