Submission Details
| 510(k) Number | K233058 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 25, 2023 |
| Decision Date | December 22, 2023 |
| Days to Decision | 88 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
Cleared
Traditional
VivaChek Link Plus Blood Glucose Monitoring System
Dec 2023
Decision
88d
Days
Class 2
Risk
About This 510(k) Submission
K233058 is an FDA 510(k) clearance for the VivaChek Link Plus 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 December 22, 2023, 88 days after receiving the submission on September 25, 2023. 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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