# Panbio Limited

- Location (FDA's records): Windsor, AU
- FDA decisions: 8 (1991–2004): 7 510(k) clearances and 1 De Novo grant
- Names in FDA's records: Panbio Limited (4); Panbio, Inc. (4)
- Product codes: NOP (3), KQJ (1), LSE (1), GRY (1), GIS (1), MIF (1)
- Predicates its devices cite: 1 (1 its own); citations of its devices by later devices: 1 (1 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Its most-cited devices
- DEN030004: West Nile Virus Igm Capture Elisa (2003), cited by 1

## Recent decisions
- K041068: West Nile Virus Igg Indirect Elisa (Oct 20, 2004)
- K041231: West Nile Virus Igm Capture Elisa, Model E-WNV02M (Aug 10, 2004)
- DEN030004: West Nile Virus Igm Capture Elisa (Jul 8, 2003)
- K030863: Ebv Vca-P18 Igg Elisa (Jun 27, 2003)
- K002024: Panbio Indx Igm Dip-S-Ticks Leptospirosis Test for the Detection of Igm Antibodies to Leptospira Biflexa (Nov 22, 2000)
- K970189: FIF TM (May 21, 1997)
- K962176: TPP (Oct 18, 1996)
- K910636: Abs Cadkit (Apr 29, 1991)

Source page: https://510kreport.com/company/panbio