FDA applicant
Immunomedics, Inc.
FDA records 4 decisions for Immunomedics, Inc. (Newark, NJ) from 1986 to 1998: 4 510(k) clearances. Most are in product codes LRM (Anti-Dna Antibody (Enzyme-Labeled), Antigen…) and CZW (Complement C3, Antigen, Antiserum, Control). 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 Immunomedics, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Immunomedics, Inc. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Immunomedics, 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) Report