FDA applicant
Allergenetics
FDA records 8 decisions for Allergenetics (Mchenry, IL) from 1982 to 1985: 8 510(k) clearances. Most are in product codes DGC (Ige, Antigen, Antiserum, Control) and DHB (System, Test, Radioallergosorbent (Rast)…). 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 Allergenetics’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Allergenetics since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Allergenetics’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