# Roche Diagnostics Hematology, Inc.

- Location (FDA's records): Westborough, MA
- FDA decisions: 1 (2018–2018): 1 510(k) clearance
- Product codes: GKZ (1)
- Predicates its devices cite: 2 (0 its own); citations of its devices by later devices: 0 (0 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Sysmex America, Inc.: 1 (https://510kreport.com/company/sysmex-america)
- CellaVision AB: 1 (https://510kreport.com/company/cellavision)

## Recent decisions
- K171655: cobas m 511 integrated hematology analyzer (Mar 2, 2018)

Source page: https://510kreport.com/company/roche-diagnostics-hematology