# Shenzhen Dakewe Bio-Engineering Co., Ltd.

- Location (FDA's records): Shenzhen, CN
- FDA decisions: 3 (2023–2024): 3 510(k) clearances
- Product codes: JSM (2), QBD (1)
- 510(k) review time since 2016: median 203 days, against 271 for FDA's reviews in the same codes and years (2 of 3 faster)
- Predicates its devices cite: 3 (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
- Copan Diagnostics, Inc.: 2 (https://510kreport.com/company/copan-diagnostics)
- Copan Italia Spa: 1 (https://510kreport.com/company/copan-italia)

## Recent decisions
- K240235: OmniTrans Transport System (Aug 19, 2024)
- K230035: BioSci™  Disposable Virus Sampling Tubes (Apr 5, 2023)
- K220059: Biosci™ Inactivated Transport Medium, Biosci™ ITM (Jan 19, 2023)

Source page: https://510kreport.com/company/shenzhen-dakewe-bio-engineering