510(k) Report

FDA applicant

Panbio Limited

Windsor, AU8 decisions1991–20041 recall

FDA records 8 decisions for Panbio Limited (Windsor, AU) from 1991 to 2004: 7 510(k) clearances and 1 De Novo grant. Most are in product codes NOP (Elisa, Antibody, West Nile Virus) and KQJ (System, Fibrinogen Determination). Its devices cite 1 predicate, 1 of them its own earlier devices. 1 recall is linked to its devices.

FDA’s records also spell it “Panbio, Inc.”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, microbiology panel, where it files most

How often FDA has decided Panbio Limited’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Panbio Limited since 2007.

Recalls per year

1in 2008

2008: 1
2007high 1 (2008) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Panbio Limited by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • NOPElisa, Antibody, West Nile Virus3decisions
  • KQJSystem, Fibrinogen Determination1decision
  • LSEEpstein-Barr Virus, Other1decision
  • GRYAntigens, All, Leptospira Spp.1decision
  • GISTest, Fibrinogen1decision
  • MIFProthrombin Fragment 1.21decision

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • DEN030004West Nile Virus Igm Capture ElisaPanbio Limited · 20031cites it

What has FDA decided for it lately?

  • K041068West Nile Virus Igg Indirect ElisaPanbio Limited · 2004
  • K041231West Nile Virus Igm Capture Elisa, Model E-WNV02MPanbio Limited · 20041 recall
  • DEN030004West Nile Virus Igm Capture ElisaPanbio Limited · 2003
  • K030863Ebv Vca-P18 Igg ElisaPanbio Limited · 2003
  • K002024Panbio Indx Igm Dip-S-Ticks Leptospirosis Test for the Detection of Igm Antibodies to Leptospira BiflexaPanbio, Inc. · 2000
  • K970189FIF TMPanbio, Inc. · 1997
  • K962176TPPPanbio, Inc. · 1996
  • K910636Abs CadkitPanbio, Inc. · 1991

All 4 as Panbio Limited →All 4 as Panbio, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K041231West Nile Virus IgM Capture ELISA The Panbio West Nile Virus IgM Capture ELISA is for…Oct 8, 2008