# Runbio Biotech Co.,Ltd

- Location (FDA's records): Shantou, CN
- FDA decisions: 3 (2006–2019): 3 510(k) clearances
- Product codes: LCX (3)
- Predicates its devices cite: 2 (0 its own); citations of its devices by later devices: 0 (0 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.: 1 (https://510kreport.com/company/guangzhou-wondfo-biotech)
- Church & Dwight Co., Inc.: 1 (https://510kreport.com/company/church-dwight)

## Recent decisions
- K181551: DAVID One Step Home Use Pregnancy Test Midstream, DAVID One Step Home Use Pregnancy Test Strip, DAVID One Step Prescription Pregnancy Test Strip, DAVID One Step Prescription Pregnancy Test Cassette, DAVID One Step Home Use Pregnancy Test Cassette (Feb 22, 2019)
- K172627: David Home Pregnancy Test Cassette, David Professional Pregnancy Test Cassette (Mar 28, 2018)
- K053236: David Pregnancy Test (Midstream) (Jul 18, 2006)

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