510(k) clearance
Safe AQ Easy Blood Glucose Monitoring System; Safe AQ Care Blood Glucose Monitoring System
- 510(k) number
- K260738
- Applicant
- Changsha Sinocare, Inc.
- Decision date
- Oct 30, 2026
- Date received
- Mar 6, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Special
- 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
- Changsha, Hunan, CN