Medical Device Manufacturer · CN , Hangzhou

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

10 submissions · 10 cleared · Since 2020

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

FDA 510(k) Regulatory Record - Vivachek Biotech (Hangzhou) Co., Ltd. Toxicology ✕

7 devices
1-7 of 7
Cleared May 22, 2026
BioSieve Multi-Drug Urine Test Panel
K261280 · NFT
Toxicology · 35d
Cleared Sep 12, 2025
Wisdiag Multi-Drug Urine Test Cup
K252554 · NFT
Toxicology · 30d
Cleared Oct 04, 2024
BioSieve™ Fentanyl FIA Home Test Kit
K241869 · NGL
Toxicology · 99d
Cleared Jun 14, 2024
BioSieve™ Fentanyl FIA Test Kit
K240124 · DJG
Toxicology · 150d
Cleared Nov 02, 2023
BioSieveTM Multi-Drug Urine Test Panel
K233062 · NFT
Toxicology · 37d
Cleared Aug 31, 2023
BioSieve™ Marijuana Test Panel 50
K231978 · NFW
Toxicology · 59d
Cleared Nov 10, 2022
Wisdiag Multi-Drug Urine Test Cup, Wisdiag Multi-Drug Urine Test Cup Rx
K222667 · NFT
Toxicology · 65d
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