FDA applicant
Nuclear Diagnostics, Inc.
FDA records 24 decisions for Nuclear Diagnostics, Inc. (Mchenry, IL) from 1977 to 2002: 24 510(k) clearances. Most are in product codes CEE (Radioimmunoassay, Thyroxine-Binding Globulin) and CDX (Radioimmunoassay, Total Thyroxine). Its devices cite 1 predicate, 1 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Nuclear Diagnostics”, “Nuclear Diagnostics AB”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Nuclear Diagnostics, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Nuclear Diagnostics, Inc. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Nuclear Diagnostics, Inc.’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) ReportOther applicant names beginning “Nuclear”
FDA records each applicant name separately; these may or may not be the same firm.