Corgenix, Inc.
Medical device manufacturer in Broomfield, CO.
23510(k) clearances
0PMA approvals
0recalls
Device types
- MSV System,Test,Antibodies,B2 - Glycoprotein I… 8
- MID System, Test, Anticardiolipin Immunological 8
- GGP Test, Qualitative And Quantitative Factor… 2
- DHC System, Test, Systemic Lupus Erythematosus 2
- LKJ Antinuclear Antibody, Antigen, Control 1
- DHN Antinuclear Antibody, Indirect… 1
- OBW 11-Dehydro Thromboxane B2 Kit, Urinary 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K072032 | Igg Anti-Atherox Test KitMSV · Traditional | 04/04/2008SE |
| K062025 | Aspirinworks Test Kit (11-DEHYDRO Thromboxane B2), Model 12136OBW · Traditional | 05/29/2007SE |
| K042680 | Rhigene Hep-Ana Test SystemDHN · Traditional | 11/19/2004SE |
| K032139 | Reaads Von Willebrand Factor Activity Test Kit, Model 10826GGP · Traditional | 04/05/2004SE |
| K034013 | Reaads Dsdna Quantitative Test Kit, Model 022-001LKJ · Special | 01/08/2004SE |
| K032868 | Reaads II Anti-Cardiolipin Igg Semi-Quantitative Test Kit, Model 11139MID · Special | 10/14/2003SE |
| K031208 | Reaads Igm ANTI-B2GPI Test Kit, Model 038-001MSV · Special | 07/07/2003SE |
| K024196 | Reeads Anti-Phosphatidylserine Igg/Igm Semi-Quantitative Test KitMID · Special | 01/03/2003SE |
| K024195 | Modification to Reaads Anti-Phosphatidylserine Iga Semi-Quantative Test KitMID · Special | 01/03/2003SE |
| K022992 | Reaads Anti-Cardiolipin Igg/Igm Semi-Quantitative Test Kit, Model 023-001MID · Special | 09/25/2002SE |
| K022990 | Reaads Iga Anti-Cardiolipin Semi-Quantitative Test Kit, Model 026-001MID · Special | 09/25/2002SE |
| K013080 | Reaads Anti-Beta 2 Glycoprotein I Igg Test KitMSV · Special | 09/28/2001SE |
| K013079 | Reaads Anti-Beta 2 Glycoprotein I Iga Test KitMSV · Special | 09/28/2001SE |
| K013077 | Reaads Anti-Beta 2 Glycoprotein I Igm Test KitMSV · Special | 09/28/2001SE |
| K013018 | Reaads Anti-Phosphatidylserine Iga Semi-Quantitive Test KitMID · Special | 09/20/2001SE |
| K012567 | Modification to: Reaads Anti-Phosphatidylserine Igg/Igm Semi-Quantitative Test KitMID · Special | 08/23/2001SE |
| K001352 | Reaads Igg Anti-Prothrombin Semi-Quantitative Test KitDHC · Traditional | 04/09/2001SE |
| K001398 | Reaads Igm Anti-Prothrombin Semi-Quantitative Test KitDHC · Traditional | 03/30/2001SE |
| K000920 | Reaads Iga Anti-Phosphatidylserine Semi-Quantitative Test KitMID · Traditional | 04/26/2000SE |
| K983914 | Reaads Monoclonal Free Protein S Antigen Test KitGGP · Traditional | 12/22/1998SE |
| K982434 | Reaads Iga ANTI-B2GP 1 Test KitMSV · Traditional | 12/22/1998SE |
| K982433 | Reaads Igm ANTI-B2GP1 Test KitMSV · Traditional | 12/07/1998SE |
| K982391 | Reaads Igg ANTI-B2GPI Test KitMSV · Traditional | 12/07/1998SE |