# Beckman Coulter Biomedical GmbH

- Location (FDA's records): Munich, DE
- FDA decisions: 1 (2019–2019): 1 510(k) clearance
- Product codes: CDD (1)
- Predicates its devices cite: 6 (0 its own); citations of its devices by later devices: 0 (0 its own)
- Recalls linked to its devices: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Beckman Coulter, Inc.: 4 (https://510kreport.com/company/beckman-coulter)
- Bio-Rad Laboratories, Inc.: 2 (https://510kreport.com/company/bio-rad-laboratories)

## Recent decisions
- K190298: DxA 5000, DxI 800 Access Immunoassay System, Access Ferritin, Access Folate, Access TSH (3rd IS), Access Vitamin B12 (Oct 4, 2019)

Source page: https://510kreport.com/company/beckman-coulter-biomedical