FDA applicant
Pan Bio Pty., Ltd.
FDA records 4 decisions for Pan Bio Pty., Ltd. (Windsor, AU) in 2002: 4 510(k) clearances. Most are in product codes GNP (Antiserum, Cf, Epstein-Barr Virus) and LSE (Epstein-Barr Virus, Other). No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Pan Bio Pty., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Pan Bio Pty., Ltd. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Pan Bio Pty., Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report