# Mindray Bio-Medical Electronics Co., Ltd.

- Location (FDA's records): Nanshan, CN
- FDA decisions: 2 (2015–2016): 2 510(k) clearances
- Product codes: GKZ (2)
- 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
- Sysmex Corp.: 1 (https://510kreport.com/company/sysmex)
- Shenzhen Mindray Bio-Medical Electronics Co., Ltd.: 1 (https://510kreport.com/company/shenzhen-mindray-bio-medical-electronics)

## Recent decisions
- K160429: BC-5390 Auto Hematology Analyzer (Sep 1, 2016)
- K143348: BC-3600 Auto Hematology Analyzer (Aug 21, 2015)

Source page: https://510kreport.com/company/mindray-bio-medical-electronics