# Vivachek Laboratories, Inc.

- Location (FDA's records): Wilmington, DE
- FDA decisions: 2 (2017–2018): 2 510(k) clearances
- Product codes: NBW (2)
- Predicates its devices cite: 3 (1 its own); citations of its devices by later devices: 3 (1 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
- Selfcare, Inc.: 1 (https://510kreport.com/company/selfcare)
- Bionostics, Inc.: 1 (https://510kreport.com/company/bionostics)

## Firms that cite its devices most
- Mio Labs, Inc.: 1 (https://510kreport.com/company/mio-labs)
- Vivachek Biotech (Hangzhou) Co., Ltd.: 1 (https://510kreport.com/company/vivachek-biotech-hangzhou)

## Its most-cited devices
- K173140: VivaChek Ino Smart Blood Glucose Monitoring System, VivaChek Ino Sync Blood Glucose Monitoring System, VivaChek Ino Sound Blood Glucose Monitoring System, VivaChek Ino Plus Blood Glucose Monitoring System, VivaChek Ino Sound Simple Blood Glucose Monitoring System, VivaChek Ino Sound Bright Blood Glucose Monitoring System (2018), cited by 2
- K160179: VivaChek Ino Blood Glucose Monitoring System (2017), cited by 1

## Recent decisions
- K173140: VivaChek Ino Smart Blood Glucose Monitoring System, VivaChek Ino Sync Blood Glucose Monitoring System, VivaChek Ino Sound Blood Glucose Monitoring System, VivaChek Ino Plus Blood Glucose Monitoring System, VivaChek Ino Sound Simple Blood Glucose Monitoring System, VivaChek Ino Sound Bright Blood Glucose Monitoring System (Dec 19, 2018)
- K160179: VivaChek Ino Blood Glucose Monitoring System (Apr 21, 2017)

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