# Ab Biodisk North America, Inc.

- Location (FDA's records): S-17136 Solna, Sweden, SE
- FDA decisions: 3 (1994–1998): 3 510(k) clearances
- Product codes: JWY (3)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 0 (0 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Recent decisions
- K983252: System U3 for Gentamicin (Nov 20, 1998)
- K950328: Amoxicillin/Clavulanic Acid 2/1 (Apr 14, 1995)
- K935519: Etest for Ampicillin/Sulbactam 2/1 (Nov 4, 1994)

Source page: https://510kreport.com/company/ab-biodisk-north-america