510(k) K231476
K231476 is an FDA 510(k) premarket notification submitted by Sinocare, Inc. for the device "TRUENESS AIR Blood Glucose Monitoring System; TRUENESS Blood Glucose Monitoring System". The FDA issued a decision of Substantially Equivalent on December 1, 2023. The device falls under product code NBW (System, Test, Blood Glucose, Over The Counter), a Class II device regulated under 21 CFR 862.1345.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 1, 2023
- Date Received
- May 22, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Test, Blood Glucose, Over The Counter
- Device Class
- Class II
- Regulation Number
- 862.1345
- Review Panel
- CH
- Submission Type