Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Immuno Concepts, N.A. , Ltd. — 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) |
|---|---|---|---|---|---|
| K203599 | Image Navigator by Immuno Concepts, Immuno Concepts IgG Anti | Immuno Concepts, N.A. , Ltd. | 2023-05-26 | 898 | 0 |
| K180202 | Histofluor Rodent LKS Fluorescent Antibody Test System, Imag | Immuno Concepts, N.A. , Ltd. | 2018-10-19 | 268 | 0 |
| K160265 | Image Navigator by Immuno Concepts | Immuno Concepts, N.A. , Ltd. | 2016-06-17 | 136 | 0 |
| K030775 | AUTO I.D. JO-1, SCL-70 & PCNA POSITIVE CONTROL SERUM | Immuno Concepts, N.A. , Ltd. | 2003-05-12 | 62 | 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