K222126
- 510(k) number
- K222126
- Device name
- VivaChek Fad Blood Glucose Monitoring System, VivaChek Fad Smart Blood Glucose Monitoring System, VivaChek Fad Sync Blood Glucose Monitoring System
- Applicant
- Vivachek Biotech (Hangzhou) Co., Ltd. CN
- Product code
- NBW — System, Test, Blood Glucose, Over The Counter
- Decision date
- 2024-08-16
- Date received
- 2022-07-18
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Clinical Chemistry
PDFDownload 510(k) SummaryArchived here · 1.1 MB · U.S. public domain
Also available from FDA: K222126.pdf
Official FDA record: K222126
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.