510(k) Report

FDA applicant

Corgenix, Inc.

Westminster, CO23 decisions1998–20081 recall

FDA records 23 decisions for Corgenix, Inc. (Westminster, CO) from 1998 to 2008: 23 510(k) clearances. Most are in product codes MID (System, Test, Anticardiolipin Immunological) and MSV (System,Test,Antibodies,B2 - Glycoprotein I (B2…). Its devices cite 8 predicates, 1 of them its own earlier devices. 1 recall is linked to its devices.

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

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

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

FDA decisions per year

1in 2008

2007: 12008: 1
2007high 1 (2007) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

1in 2009

2009: 1
2007high 1 (2009) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Corgenix, Inc.’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

Which product codes does it file in?

  • MIDSystem, Test, Anticardiolipin Immunological8decisions
  • MSVSystem,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)8decisions
  • DHCSystem, Test, Systemic Lupus Erythematosus2decisions
  • GGPTest, Qualitative And Quantitative Factor Deficiency2decisions
  • LKJAntinuclear Antibody, Antigen, Control1decision
  • OBW11-Dehydro Thromboxane B2 Kit, Urinary1decision

Also: DHN (1).

Whose devices does it build on?

Its devices cite 8 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 7 times; 1 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K022992Reaads Anti-Cardiolipin Igg/Igm Semi-Quantitative Test Kit, Model 023-001Corgenix, Inc. · 20023cite it
  • K031208Reaads Igm Anti-B2GPI Test Kit, Model 038-001Corgenix, Inc. · 20031cites it
  • K022990Reaads Iga Anti-Cardiolipin Semi-Quantitative Test Kit, Model 026-001Corgenix, Inc. · 20021cites it
  • K013079Reaads Anti-Beta 2 Glycoprotein I Iga Test KitCorgenix, Inc. · 20011cites it
  • K013080Reaads Anti-Beta 2 Glycoprotein I Igg Test KitCorgenix, Inc. · 20011cites it

What has FDA decided for it lately?

  • K072032Igg Anti-Atherox Test KitCorgenix, Inc. · 2008
  • K062025Aspirinworks Test Kit (11-Dehydro Thromboxane B2), Model 12136Corgenix, Inc. · 2007
  • K042680Rhigene Hep-Ana Test SystemCorgenix, Inc. · 2004
  • K032139Reaads Von Willebrand Factor Activity Test Kit, Model 10826Corgenix, Inc. · 2004
  • K034013Reaads Dsdna Quantitative Test Kit, Model 022-001Corgenix, Inc. · 2004
  • K032868Reaads II Anti-Cardiolipin Igg Semi-Quantitative Test Kit, Model 11139Corgenix, Inc. · 20031 recall
  • K031208Reaads Igm Anti-B2GPI Test Kit, Model 038-001Corgenix, Inc. · 2003
  • K024196Reeads Anti-Phosphatidylserine Igg/Igm Semi-Quantitative Test KitCorgenix, Inc. · 2003

All 23 as Corgenix, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K032868BIO-RAD 425-2020 Autoimmune EIA Anti-Cardiolipin IgM, 96 Tests...2010 02 16...Lot…Jul 14, 2009