Submission Details
| 510(k) Number | K222126 FDA.gov |
| FDA Decision | Cleared 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 |
Cleared
Traditional
VivaChek? Fad Blood Glucose Monitoring System, VivaChek? Fad Smart Blood Glucose Monitoring System, VivaChek? Fad Sync Blood Glucose Monitoring System
Aug 2024
Decision
760d
Days
Class 2
Risk
About This 510(k) Submission
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, 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 review panel. Regulated under 21 CFR 862.1345.
Device Classification
| Product Code | NBW — System, Test, Blood Glucose, Over The Counter |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 862.1345 |
Manufacturer
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