K233058
- 510(k) number
- K233058
- Device name
- VivaChek Link Plus Blood Glucose Monitoring System
- Applicant
- Vivachek Biotech (Hangzhou) Co., Ltd. CN
- Product code
- NBW — System, Test, Blood Glucose, Over The Counter
- Decision date
- 2023-12-22
- Date received
- 2023-09-25
- 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: K233058.pdf
Official FDA record: K233058
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.