Company · CN
Vivachek Biotech (Hangzhou) Co., Ltd.
FDA 510(k) clearances and medical device recalls filed under this name, 2020 to 2026. Name variants (Inc, Corp, punctuation) are merged.
11510(k) clearances (2 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 9, 2026 | K260687 | VivaChek Blood Glucose and ß-Ketone Dual BLE Monitoring System;VivaChek Blood Glucose and ß-Ketone Dual Monitoring Syste Vivachek Biotech (Hangzhou) Co., Ltd., CN | NBW |
| May 22, 2026 | K261280 | BioSieve Multi-Drug Urine Test Panel;BioSieve Multi-Drug Urine Home Test Panel Vivachek Biotech (Hangzhou) Co., Ltd., CN | NFT |
| Sep 12, 2025 | K252554 | Wisdiag Multi-Drug Urine Test Cup; Wisdiag Multi-Drug Urine Home Test Cup Vivachek Biotech (Hangzhou) Co., Ltd., CN | NFT |
| Oct 4, 2024 | K241869 | BioSieve Fentanyl FIA Home Test Kit; BioSieve Fentanyl FIA Pro Test Kit; BioSieve Toxismart Reader Vivachek Biotech (Hangzhou) Co., Ltd., CN | NGL |
| Aug 16, 2024 | K222126 | VivaChek Fad Blood Glucose Monitoring System, VivaChek Fad Smart Blood Glucose Monitoring System, VivaChek Fad Sync B Vivachek Biotech (Hangzhou) Co., Ltd., CN | NBW |
| Jun 14, 2024 | K240124 | BioSieve Fentanyl FIA Test Kit; BioSieve ToxiSmart FIA Reader Vivachek Biotech (Hangzhou) Co., Ltd., CN | DJG |
| Dec 22, 2023 | K233058 | VivaChek Link Plus Blood Glucose Monitoring System Vivachek Biotech (Hangzhou) Co., Ltd., CN | NBW |
| Nov 2, 2023 | K233062 | BioSieveTM Multi-Drug Urine Test Panel; BioSieveTM Multi-Drug Urine Test Panel Rx Vivachek Biotech (Hangzhou) Co., Ltd., CN | NFT |
| Aug 31, 2023 | K231978 | BioSieve Marijuana Test Panel 50; BioSieve Marijuana Test Strip 50; BioSieve Dx Marijuana Test Strip 20; BioSieve Dx Vivachek Biotech (Hangzhou) Co., Ltd., CN | NFW |
| Nov 10, 2022 | K222667 | Wisdiag Multi-Drug Urine Test Cup, Wisdiag Multi-Drug Urine Test Cup Rx Vivachek Biotech (Hangzhou) Co., Ltd., CN | NFT |
| Jun 5, 2020 | K192957 | VivaChek Blood Glucose and B-Ketone Monitoring System Vivachek Biotech (Hangzhou) Co., Ltd., CN | JIN |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||