K231192
- 510(k) number
- K231192
- Device name
- RIGHTEST Blood Glucose Monitoring System Max Tel
- Applicant
- Bionime Corporation TW
- Product code
- NBW — System, Test, Blood Glucose, Over The Counter
- Decision date
- 2024-01-19
- Date received
- 2023-04-27
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Clinical Chemistry
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K231192.pdf
Official FDA record: K231192
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.