# Selux Diagnostics, Inc.

- Location (FDA's records): Charlestown, MA
- FDA decisions: 4 (2023–2025): 4 510(k) clearances
- Product codes: QZX (2), LON (2)
- Predicates its devices cite: 4 (1 its own); citations of its devices by later devices: 1 (1 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
- Becton, Dickinson & CO: 2 (https://510kreport.com/company/becton-dickinson)
- Avails Medical, Inc.: 1 (https://510kreport.com/company/avails-medical)

## Its most-cited devices
- K223493: PBC Separator with Selux AST System (2024), cited by 1

## Recent decisions
- K244044: PBC Separator with Selux AST System (Mar 28, 2025)
- K223493: PBC Separator with Selux AST System (Feb 15, 2024)
- K211748: Selux AST System; Model AST Gen 1.0 (Apr 19, 2023)
- K211759: Selux AST System; Model AST Gen 1.0 (Jan 18, 2023)

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