Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Immunetech Corporation — 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) |
|---|---|---|---|---|---|
| K061979 | MODIFICATION TO MYALLERGY TEST | Immunetech Corporation | 2006-09-22 | 71 | 6 |
| K032251 | IMMUNETECH TOTAL IGE SYSTEM | Immunetech Corporation | 2003-12-19 | 150 | 0 |
| K021698 | MY ALLERGY TEST | Immunetech Corporation | 2002-09-19 | 120 | 6 |
| K020387 | MYALLERGYTEST SYSTEM | Immunetech Corporation | 2002-04-17 | 71 | 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