# Karo Bio Diagnostics AB

- Location (FDA's records): S-141 44 Huddinge, Sweden, SC
- FDA decisions: 1 (1992–1992): 1 510(k) clearance
- Product codes: LIC (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
- K921075: Phadebact Monoclonal GC Test, Modification (May 22, 1992)

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