# Ssi Diagnostica A/S

- Location (FDA's records): Hilleroed, DK
- FDA decisions: 1 (2020–2020): 1 510(k) clearance
- Product codes: MJH (1)
- Predicates its devices cite: 4 (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
- Binax, Inc.: 3 (https://510kreport.com/company/binax)
- Inverness Medical Professional Diagnostics: 1 (https://510kreport.com/company/inverness-medical-professional-diagnostics)

## Recent decisions
- K191184: ImmuView S pneumoniae and L pneumophila Urinary Antigen Test (Mar 5, 2020)

Source page: https://510kreport.com/company/ssi-diagnostica-a-s