# Qualisys Diagnostics, Inc.

- Location (FDA's records): Carlsbad, CA
- FDA decisions: 2 (1999–2000): 2 510(k) clearances
- Product codes: LTJ (2)
- Predicates its devices cite: 3 (0 its own); citations of its devices by later devices: 0 (0 its own)
- Recalls linked to its devices: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Abbott Laboratories: 3 (https://510kreport.com/company/abbott-laboratories)

## Recent decisions
- K994419: Fastpack Psa Immunoassay, Fastpack System (Jun 28, 2000)
- K990234: Qualisys Psa Immunoassay (Jul 8, 1999)

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