# Corgenix, Inc.

- Location (FDA's records): Westminster, CO
- FDA decisions: 23 (1998–2008): 23 510(k) clearances
- Product codes: MID (8), MSV (8), DHC (2), GGP (2), LKJ (1), OBW (1), DHN (1)
- Predicates its devices cite: 8 (1 its own); citations of its devices by later devices: 7 (1 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Inova Diagnostics, Inc.: 3 (https://510kreport.com/company/inova-diagnostics)
- Shield Diagnostics, Ltd.: 1 (https://510kreport.com/company/shield-diagnostics)
- Accumetrics, Inc.: 1 (https://510kreport.com/company/accumetrics)
- Bion Ent., Ltd.: 1 (https://510kreport.com/company/bion-ent)
- Reaads Medical Products, Inc.: 1 (https://510kreport.com/company/reaads-medical-products)

## Firms that cite its devices most
- Bio-Rad Laboratories, Inc.: 4 (https://510kreport.com/company/bio-rad-laboratories)
- Instrumentation Laboratory CO: 2 (https://510kreport.com/company/instrumentation-laboratory)

## Its most-cited devices
- K022992: Reaads Anti-Cardiolipin Igg/Igm Semi-Quantitative Test Kit, Model 023-001 (2002), cited by 3
- K031208: Reaads Igm Anti-B2GPI Test Kit, Model 038-001 (2003), cited by 1
- K022990: Reaads Iga Anti-Cardiolipin Semi-Quantitative Test Kit, Model 026-001 (2002), cited by 1
- K013079: Reaads Anti-Beta 2 Glycoprotein I Iga Test Kit (2001), cited by 1
- K013080: Reaads Anti-Beta 2 Glycoprotein I Igg Test Kit (2001), cited by 1

## Recent decisions
- K072032: Igg Anti-Atherox Test Kit (Apr 4, 2008)
- K062025: Aspirinworks Test Kit (11-Dehydro Thromboxane B2), Model 12136 (May 29, 2007)
- K042680: Rhigene Hep-Ana Test System (Nov 19, 2004)
- K032139: Reaads Von Willebrand Factor Activity Test Kit, Model 10826 (Apr 5, 2004)
- K034013: Reaads Dsdna Quantitative Test Kit, Model 022-001 (Jan 8, 2004)
- K032868: Reaads II Anti-Cardiolipin Igg Semi-Quantitative Test Kit, Model 11139 (Oct 14, 2003)
- K031208: Reaads Igm Anti-B2GPI Test Kit, Model 038-001 (Jul 7, 2003)
- K024196: Reeads Anti-Phosphatidylserine Igg/Igm Semi-Quantitative Test Kit (Jan 3, 2003)

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