Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
New England Immunology Assoc. · 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) |
|---|---|---|---|---|---|
| K813288 | NEIA TRANSFERRIN ENZYMEIMMUNOASSAY | New England Immunology Assoc. | 1981-12-17 | 24 | 0 |
| K811757 | NEIA PAP ENZYMEIMMUNOASSAY | New England Immunology Assoc. | 1981-08-13 | 52 | 0 |
| K790490 | NEIA-FERRITIN ENZYMEIMMUNASSAY KIT | New England Immunology Assoc. | 1979-04-23 | 46 | 0 |
| K780490 | NEIA-FERRITIN ENZYMEIMMUNOASSAY | New England Immunology Assoc. | 1978-04-10 | 14 | 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