Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Immunomedics, Inc. — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K972873 | IMMUSTRIP HAMA IGG | Immunomedics, Inc. | 1998-03-17 | 225 | 0 |
| K873741 | IMMUSTRIP(TM) SM ELISA TEST SYSTEM | Immunomedics, Inc. | 1987-11-04 | 49 | 0 |
| K870903 | IMMUSTRIP(TM) DSDNA ELISA TEST SYSTEM | Immunomedics, Inc. | 1987-05-14 | 70 | 0 |
| K861362 | IMMUNOMEDICS SERUM ELISA TEST SYSTEM | Immunomedics, Inc. | 1986-06-06 | 57 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda