# Sysmex Corporation of America

- Location (FDA's records): Long Grove, IL
- FDA decisions: 3 (2000–2002): 3 510(k) clearances
- Product codes: GKZ (2), GKL (1)
- Predicates its devices cite: 1 (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)

## Recent decisions
- K021241: Sysmex XT-Series, Model XT-2000I and XT-1800I (Jun 25, 2002)
- K020496: HPC (Hematopoietic Progenitor Cell) Parameter on the Imi Channel of the Sysmex SE-9500 and XE-2100, Automated Hematology (Apr 12, 2002)
- K001683: Sysmex R-500 (Aug 21, 2000)

Source page: https://510kreport.com/company/sysmex-of-america