FDA applicant
New England Nuclear
FDA records 18 decisions for New England Nuclear (Mchenry, IL) from 1976 to 1984: 18 510(k) clearances. Most are in product codes DJB (Radioimmunoassay, Gentamicin (125-I), Second…) and CGR (Radioimmunoassay, Cortisol). 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 New England Nuclear’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for New England Nuclear since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like New England Nuclear’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