FDA applicant
Genbio
FDA records 10 decisions for Genbio (San Diego, CA) from 1996 to 2001: 10 510(k) clearances. Most are in product codes LSE (Epstein-Barr Virus, Other) and LJZ (Enzyme Linked Immunoabsorbent Assay…). 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 Genbio’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Genbio since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Genbio’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report