Vivachek Biotech (Hangzhou) Co., Ltd. is one of 1554 FDA 510(k) medical device manufacturers from China in the dataset, ranked by real submission volume.
Vivachek Biotech (Hangzhou) Co., Ltd. - FDA 510(k) Cleared Devices
Recent clearances: BioSieve Multi-Drug Urine Test Panel, Wisdiag Multi-Drug Urine Test Cup, BioSieve™ Fentanyl FIA Home Test Kit
10
Total
10
Cleared
0
Denied
Vivachek Biotech (Hangzhou) Co., Ltd. has 10 FDA 510(k) cleared toxicology devices. Based in Hangzhou, CN.
Latest FDA clearance: May 2026. Active since 2020.
Browse the complete list of FDA 510(k) cleared toxicology devices from this manufacturer. Filter by specialty or product code using the sidebar.
Regulatory submissions have been managed by LSI International, Inc. and Lsi International.
FDA 510(k) Regulatory Record - Vivachek Biotech (Hangzhou) Co., Ltd.
10 devices
Cleared
May 22, 2026
BioSieve Multi-Drug Urine Test Panel
Toxicology
35d
Cleared
Sep 12, 2025
Wisdiag Multi-Drug Urine Test Cup
Toxicology
30d
Cleared
Oct 04, 2024
BioSieve™ Fentanyl FIA Home Test Kit
Toxicology
99d
Cleared
Aug 16, 2024
VivaChek™ Fad Blood Glucose Monitoring System, VivaChek™ Fad Smart Blood...
Chemistry
760d
Cleared
Jun 14, 2024
BioSieve™ Fentanyl FIA Test Kit
Toxicology
150d
Cleared
Dec 22, 2023
VivaChek Link Plus Blood Glucose Monitoring System
Chemistry
88d
Cleared
Nov 02, 2023
BioSieveTM Multi-Drug Urine Test Panel
Toxicology
37d
Cleared
Aug 31, 2023
BioSieve™ Marijuana Test Panel 50
Toxicology
59d
Cleared
Nov 10, 2022
Wisdiag Multi-Drug Urine Test Cup, Wisdiag Multi-Drug Urine Test Cup Rx
Toxicology
65d
Cleared
Jun 05, 2020
VivaChek Blood Glucose and B-Ketone Monitoring System
Chemistry
228d