FDA 510(k) Applications Submitted by VivaChek Biotech (Hangzhou) Co., Ltd
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K231978 |
07/03/2023 |
BioSieveÖ Marijuana Test Panel 50; BioSieveÖ Marijuana Test Strip 50; BioSieveÖ Dx Marijuana Test Strip 20; BioSieveÖ Dx Marijuana Test Strip 50; BioSieveÖ Dx Marijuana Test Panel 20; BioSieveÖ Dx Marijuana Test Panel 50 |
VivaChek Biotech (Hangzhou) Co., Ltd |
| K222667 |
09/06/2022 |
Wisdiag Multi-Drug Urine Test Cup, Wisdiag Multi-Drug Urine Test Cup Rx |
Vivachek Biotech (Hangzhou) Co., Ltd |
| K233062 |
09/26/2023 |
BioSieveTM Multi-Drug Urine Test Panel; BioSieveTM Multi-Drug Urine Test Panel Rx |
VivaChek Biotech (Hangzhou) Co., Ltd |
| K222126 |
07/18/2022 |
VivaChekÖ Fad Blood Glucose Monitoring System, VivaChekÖ Fad Smart Blood Glucose Monitoring System, VivaChekÖ Fad Sync Blood Glucose Monitoring System |
Vivachek Biotech (Hangzhou) Co., Ltd |
| K192957 |
10/21/2019 |
VivaChek Blood Glucose and B-Ketone Monitoring System |
Vivachek Biotech (Hangzhou) Co., Ltd |
| K240124 |
01/16/2024 |
BioSieveÖ Fentanyl FIA Test Kit; BioSieveÖ ToxiSmart FIA Reader |
VivaChek Biotech (Hangzhou) Co., Ltd |
| K241869 |
06/27/2024 |
BioSieveÖ Fentanyl FIA Home Test Kit; BioSieveÖ Fentanyl FIA Pro Test Kit; BioSieveÖ Toxismart Reader |
VivaChek Biotech (Hangzhou) Co., Ltd |
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