FDA applicant
Karo Bio Diagnostics AB
FDA records 1 decision for Karo Bio Diagnostics AB (S-141 44 Huddinge, Sweden, SC) in 1992: 1 510(k) clearance. All are in product code LIC (Antiserum, Coagglutination (Direct) Neisseria…). No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Karo Bio Diagnostics AB’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Karo Bio Diagnostics AB since 2007.
Recalls per year
No recall linked to its devices since 2007.
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