Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Panbio Limited — 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) |
|---|---|---|---|---|---|
| K041068 | WEST NILE VIRUS IGG INDIRECT ELISA | Panbio Limited | 2004-10-20 | 177 | 0 |
| K041231 | WEST NILE VIRUS IGM CAPTURE ELISA, MODEL E-WNV02M | Panbio Limited | 2004-08-10 | 92 | 1 |
| DEN030004 | WEST NILE VIRUS IGM CAPTURE ELISA | Panbio Limited | 2003-07-08 | 5 | 0 |
| K030863 | EBV VCA-P18 IGG ELISA | Panbio Limited | 2003-06-27 | 101 | 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