# Bion Diagnostic Sciences

- Location (FDA's records): Redmond, WA
- FDA decisions: 1 (2001–2001): 1 510(k) clearance
- Product codes: JHI (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
- K012559: Poly Stat HCG Test (Oct 16, 2001)

Source page: https://510kreport.com/company/bion-diagnostic-sciences