# Healstone Biotech, Inc.

- Location (FDA's records): Vancouver, CA
- FDA decisions: 3 (2019–2022): 3 510(k) clearances
- Product codes: NFT (2), LCX (1)
- Predicates its devices cite: 3 (1 its own); citations of its devices by later devices: 1 (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
- Church & Dwight Co., Inc.: 1 (https://510kreport.com/company/church-dwight)
- Guangzhou Wondfo Biotech Co., Ltd.: 1 (https://510kreport.com/company/guangzhou-wondfo-biotech)

## Its most-cited devices
- K191841: Accurate Multi Panel Drug Urine Test Cup (2019), cited by 1

## Recent decisions
- K221871: Healstone Accurate (TM) Drug of Abuse Urine Test Cup, Healstone Accurate (TM) Drug of Abuse Urine Test Cup Rx (Aug 30, 2022)
- K212418: hCG One Step Pregnancy Test (Jun 30, 2022)
- K191841: Accurate Multi Panel Drug Urine Test Cup (Aug 7, 2019)

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