K231476
- 510(k) number
- K231476
- Device name
- TRUENESS AIR Blood Glucose Monitoring System; TRUENESS Blood Glucose Monitoring System
- Applicant
- Sinocare, Inc. CN
- Product code
- NBW — System, Test, Blood Glucose, Over The Counter
- Decision date
- 2023-12-01
- Date received
- 2023-05-22
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Clinical Chemistry
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K231476.pdf
Official FDA record: K231476
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.