# Shenzhen New Industries Biomedical Engineering Co., Ltd.

- Location (FDA's records): Shenzhen, CN
- FDA decisions: 5 (2017–2024): 5 510(k) clearances
- Product codes: MRG (2), JLW (1), CEC (1), DHA (1)
- Predicates its devices cite: 7 (2 its own); citations of its devices by later devices: 2 (2 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
- Siemens Healthcare Diagnostics, Inc.: 3 (https://510kreport.com/company/siemens-healthcare-diagnostics)
- DiaSorin, Inc.: 1 (https://510kreport.com/company/diasorin)
- Beckman Coulter, Inc.: 1 (https://510kreport.com/company/beckman-coulter)

## Its most-cited devices
- K162698: MAGLUMI 2000 TSH, MAGLUMI 2000 Immunoassay Analyzer (2017), cited by 1
- K191499: MAGLUMI 2000 25-OH Vitamin D (2019), cited by 1

## Recent decisions
- K232587: MAGLUMI 25-OH Vitamin D, MAGLUMI X3 Fully-auto chemiluminescence immunoassay analyzer (Apr 12, 2024)
- K192547: Maglumi  2000 HCG/ß-HCG (Jan 17, 2020)
- K191499: MAGLUMI 2000 25-OH Vitamin D (Aug 1, 2019)
- K182423: Maglumi 2000 FT4 (Oct 4, 2018)
- K162698: MAGLUMI 2000 TSH, MAGLUMI 2000 Immunoassay Analyzer (Jul 14, 2017)

Source page: https://510kreport.com/company/shenzhen-new-industries-biomedical-engineering