# K-Systems, Kivex Biotec, Ltd.

- Location (FDA's records): Birkerod, DK
- FDA decisions: 1 (2001–2001): 1 510(k) clearance
- Product codes: MQG (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
- K013401: K-Systems Culture Bag Sealer and Culture Bags Type CBS-1 and CB-01 (Dec 14, 2001)

Source page: https://510kreport.com/company/k-systems-kivex-biotec