Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Kronus — 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) |
|---|---|---|---|---|---|
| K915429 | KRONUS KALIBRE THYROID PEROXIDASE ANTIBODY EIA KIT | Kronus | 1992-03-30 | 119 | 0 |
| K915428 | KRONUS KALIBRE THYROGLOBULIN ANTIBODY EIA KIT | Kronus | 1992-03-30 | 119 | 0 |
| K894203 | ANTI-THYROGLOBULIN TEST KIT | Kronus | 1989-07-25 | 36 | 0 |
| K894364 | MODIFIED KRONUS TEST KIT FOR ANTIBODIES TO (TPO) | Kronus | 1989-07-25 | 11 | 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