K250085
- 510(k) number
- K250085
- Device name
- On Call® Sure GK Blood Glucose & Ketone Monitoring System; On Call® Sure Sync GK Blood Glucose & Ketone Monitoring System
- Applicant
- ACON Laboratories, Inc. CA · US
- Product code
- NBW — System, Test, Blood Glucose, Over The Counter
- Decision date
- 2025-10-10
- Date received
- 2025-01-13
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Clinical Chemistry
This submission filed a 510(k) Statement rather than a Summary; no public summary is available from FDA.
Official FDA record: K250085
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.