K222126 is an FDA 510(k) clearance for the VivaChek™ Fad Blood Glucose Monitoring System, VivaChek™ Fad Smart Blood Glucose Monitoring System, VivaChek™ Fad Sync Blood Glucose Monitoring System. This device is classified as a System, Test, Blood Glucose, Over The Counter (Class II - Special Controls, product code NBW).
Submitted by Vivachek Biotech (Hangzhou) Co., Ltd. (Hangzhou, CN). The FDA issued a Cleared decision on August 16, 2024, 760 days after receiving the submission on July 18, 2022.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1345.
| 510(k) Number | K222126 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 18, 2022 |
| Decision Date | August 16, 2024 |
| Days to Decision | 760 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | NBW - System, Test, Blood Glucose, Over The Counter |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1345 |