# Vivachek Biotech (Hangzhou) Co., Ltd.

- Location (FDA's records): Hangzhou, CN
- FDA decisions: 11 (2020–2026): 11 510(k) clearances
- Product codes: NFT (4), NBW (3), DJG (1), NFW (1), NGL (1), JIN (1)
- 510(k) review time since 2016: median 94 days, against 107 for FDA's reviews in the same codes and years (2 of 8 faster)
- Predicates its devices cite: 10 (3 its own); citations of its devices by later devices: 5 (3 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Guangzhou Wondfo Biotech Co., Ltd.: 2 (https://510kreport.com/company/guangzhou-wondfo-biotech)
- Shenzhen Superbio Technology Co., Ltd.: 1 (https://510kreport.com/company/shenzhen-superbio-technology)
- Vivachek Laboratories, Inc.: 1 (https://510kreport.com/company/vivachek-laboratories)
- Shenzhen Bioeasy Biotechnology Co., Ltd.: 1 (https://510kreport.com/company/shenzhen-bioeasy-biotechnology)
- I-Sens, Inc.: 1 (https://510kreport.com/company/i-sens)
- Taidoc Technology Corporation: 1 (https://510kreport.com/company/taidoc-technology)

## Firms that cite its devices most
- Guangdong Transtek Medical Electronics Co., Ltd.: 1 (https://510kreport.com/company/guangdong-transtek-medical-electronics)
- Healgen Scientific,, LLC: 1 (https://510kreport.com/company/healgen-scientific)

## Its most-cited devices
- K240124: BioSieve™ Fentanyl FIA Test Kit; BioSieve™ ToxiSmart FIA Reader (2024), cited by 2
- K233058: VivaChek Link Plus Blood Glucose Monitoring System (2023), cited by 1
- K222667: Wisdiag Multi-Drug Urine Test Cup, Wisdiag Multi-Drug Urine Test Cup Rx (2022), cited by 1
- K233062: BioSieveTM Multi-Drug Urine Test Panel; BioSieveTM Multi-Drug Urine Test Panel Rx (2023), cited by 1

## Recent decisions
- K260687: VivaChek Blood Glucose and ß-Ketone Dual BLE Monitoring System;VivaChek Blood Glucose and ß-Ketone Dual Monitoring System. (Oct 9, 2026)
- K261280: BioSieve Multi-Drug Urine Test Panel;BioSieve Multi-Drug Urine Home Test Panel (May 22, 2026)
- K252554: Wisdiag Multi-Drug Urine Test Cup; Wisdiag Multi-Drug Urine Home Test Cup (Sep 12, 2025)
- K241869: BioSieve™ Fentanyl FIA Home Test Kit; BioSieve™ Fentanyl FIA Pro Test Kit; BioSieve™ Toxismart Reader (Oct 4, 2024)
- K222126: VivaChek™ Fad Blood Glucose Monitoring System, VivaChek™ Fad Smart Blood Glucose Monitoring System, VivaChek™ Fad Sync Blood Glucose Monitoring System (Aug 16, 2024)
- K240124: BioSieve™ Fentanyl FIA Test Kit; BioSieve™ ToxiSmart FIA Reader (Jun 14, 2024)
- K233058: VivaChek Link Plus Blood Glucose Monitoring System (Dec 22, 2023)
- K233062: BioSieveTM Multi-Drug Urine Test Panel; BioSieveTM Multi-Drug Urine Test Panel Rx (Nov 2, 2023)

Source page: https://510kreport.com/company/vivachek-biotech-hangzhou