Medical Device Manufacturer · CN , Hangzhou

Vivachek Biotech (Hangzhou) Co., Ltd. - FDA 510(k) Cleared Devices

9 submissions · 9 cleared · Since 2020

9

Total

9

Cleared

0

Denied

FDA 510(k) cleared devices by Vivachek Biotech (Hangzhou) Co., Ltd. Toxicology ✕

6 devices

1-6 of 6

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 Jun 14, 2024

BioSieve™ Fentanyl FIA Test Kit

Toxicology · 150d

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