# Diasys Diagnostics Systems GmbH

- Location (FDA's records): Holzheim, Rheinland-Pfalz, DE
- FDA decisions: 1 (2008–2008): 1 510(k) clearance
- Product codes: CIT (1)
- Predicates its devices cite: 3 (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
- Roche Diagnostics Corp.: 2 (https://510kreport.com/company/roche-diagnostics)
- Roche Diagnostic Systems, Inc.: 1 (https://510kreport.com/company/roche-diagnostic-systems)

## Recent decisions
- K080485: Aspartate Amino Transferase (Ast/Sgot) Test System, Asat (Got) FS (Dec 4, 2008)

Source page: https://510kreport.com/company/diasys-diagnostics-systems