# Boehringer Mannheim Italia Spa

- Location (FDA's records): Simi Valley, CA
- FDA decisions: 3 (1994–1996): 3 510(k) clearances
- Product codes: JHI (2), LCX (1)
- Predicates its devices cite: 0 (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

## Recent decisions
- K955266: Accustat HCG Serum Diluent Reagent or Event Serum Diluent (Feb 29, 1996)
- K936013: Evatest Strip (Feb 25, 1994)
- K935502: Event Test Strip HCG (Jan 27, 1994)

Source page: https://510kreport.com/company/boehringer-mannheim-italia