Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Pan Bio Pty. , 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) |
|---|---|---|---|---|---|
| K021793 | EBV EA-D IGG ELISA KIT, MODEL EBG-100 | Pan Bio Pty. , Ltd. | 2002-09-27 | 119 | 0 |
| K020717 | EBV V VCA IGM ELISA KIT MODEL# EBM-200 | Pan Bio Pty. , Ltd. | 2002-06-13 | 100 | 0 |
| K020706 | EBV-VCA IGG ELISA TEST, MODEL EBG-100 | Pan Bio Pty. , Ltd. | 2002-06-13 | 101 | 0 |
| K020707 | EBV-EBNA IGG ELISA KIT, MODEL EBG-100 | Pan Bio Pty. , Ltd. | 2002-06-13 | 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