| BioSieve Multi-Drug Urine Test Panel;BioSieve Multi-Drug Urine Home Test Panel (K261280) | Vivachek Biotech (Hangzhou) Co., Ltd. | 2026-05-22 |
| Wisdiag Multi-Drug Urine Test Cup; Wisdiag Multi-Drug Urine Home Test Cup (K252554) | Vivachek Biotech (Hangzhou) Co., Ltd. | 2025-09-12 |
| BioSieve™ Fentanyl FIA Home Test Kit; BioSieve™ Fentanyl FIA Pro Test Kit; BioSieve™ Toxismart Reader (K241869) | Vivachek Biotech (Hangzhou) Co., Ltd. | 2024-10-04 |
| VivaChek™ Fad Blood Glucose Monitoring System, VivaChek™ Fad Smart Blood Glucose Monitoring System, VivaChek™ Fad Sync Blood Glucose Monitoring System (K222126) | Vivachek Biotech (Hangzhou) Co., Ltd. | 2024-08-16 |
| BioSieve™ Fentanyl FIA Test Kit; BioSieve™ ToxiSmart FIA Reader (K240124) | Vivachek Biotech (Hangzhou) Co., Ltd. | 2024-06-14 |
| VivaChek Link Plus Blood Glucose Monitoring System (K233058) | Vivachek Biotech (Hangzhou) Co., Ltd. | 2023-12-22 |
| BioSieveTM Multi-Drug Urine Test Panel; BioSieveTM Multi-Drug Urine Test Panel Rx (K233062) | Vivachek Biotech (Hangzhou) Co., Ltd. | 2023-11-02 |
| BioSieve™ Marijuana Test Panel 50; BioSieve™ Marijuana Test Strip 50; BioSieve™ Dx Marijuana Test Strip 20; BioSieve™ Dx Marijuana Test Strip 50; BioSieve™ Dx Marijuana Test Panel 20; BioSieve™ Dx Marijuana Test Panel 50 (K231978) | Vivachek Biotech (Hangzhou) Co., Ltd. | 2023-08-31 |
| Wisdiag Multi-Drug Urine Test Cup, Wisdiag Multi-Drug Urine Test Cup Rx (K222667) | Vivachek Biotech (Hangzhou) Co., Ltd. | 2022-11-10 |
| VivaChek Blood Glucose and B-Ketone Monitoring System (K192957) | Vivachek Biotech (Hangzhou) Co., Ltd. | 2020-06-05 |