Corgenix, Inc.
Broomfield, CO, US
CORGENIX, INC. appears in FDA device records in Broomfield, CO. FDA records list 23 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 23 510(k) clearances for Corgenix, Inc. between 1998 and 2008. The busiest year on record is 2001, with 7. The most recent is 2008, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1998 | 4 |
| 2000 | 1 |
| 2001 | 7 |
| 2002 | 2 |
| 2003 | 4 |
| 2004 | 3 |
| 2007 | 1 |
| 2008 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K072032 | IGG ANTI-ATHEROX TEST KIT | MSV | Substantially Equivalent | |
| K062025 | ASPIRINWORKS TEST KIT (11-DEHYDRO THROMBOXANE B2), MODEL 12136 | OBW | Substantially Equivalent | |
| K042680 | RHIGENE HEP-ANA TEST SYSTEM | DHN | Substantially Equivalent | |
| K032139 | REAADS VON WILLEBRAND FACTOR ACTIVITY TEST KIT, MODEL 10826 | GGP | Substantially Equivalent | |
| K034013 | REAADS DSDNA QUANTITATIVE TEST KIT, MODEL 022-001 | LKJ | Substantially Equivalent | |
| K032868 | REAADS II ANTI-CARDIOLIPIN IGG SEMI-QUANTITATIVE TEST KIT, MODEL 11139 | MID | Substantially Equivalent | |
| K031208 | REAADS IGM ANTI-B2GPI TEST KIT, MODEL 038-001 | MSV | Substantially Equivalent | |
| K024196 | REEADS ANTI-PHOSPHATIDYLSERINE IGG/IGM SEMI-QUANTITATIVE TEST KIT | MID | Substantially Equivalent | |
| K024195 | MODIFICATION TO REAADS ANTI-PHOSPHATIDYLSERINE IGA SEMI-QUANTATIVE TEST KIT | MID | Substantially Equivalent | |
| K022992 | REAADS ANTI-CARDIOLIPIN IGG/IGM SEMI-QUANTITATIVE TEST KIT, MODEL 023-001 | MID | Substantially Equivalent | |
| K022990 | REAADS IGA ANTI-CARDIOLIPIN SEMI-QUANTITATIVE TEST KIT, MODEL 026-001 | MID | Substantially Equivalent | |
| K013080 | REAADS ANTI-BETA 2 GLYCOPROTEIN I IGG TEST KIT | MSV | Substantially Equivalent | |
| K013079 | REAADS ANTI-BETA 2 GLYCOPROTEIN I IGA TEST KIT | MSV | Substantially Equivalent | |
| K013077 | REAADS ANTI-BETA 2 GLYCOPROTEIN I IGM TEST KIT | MSV | Substantially Equivalent | |
| K013018 | REAADS ANTI-PHOSPHATIDYLSERINE IGA SEMI-QUANTITIVE TEST KIT | MID | Substantially Equivalent | |
| K012567 | MODIFICATION TO: REAADS ANTI-PHOSPHATIDYLSERINE IGG/IGM SEMI-QUANTITATIVE TEST KIT | MID | Substantially Equivalent | |
| K001352 | REAADS IGG ANTI-PROTHROMBIN SEMI-QUANTITATIVE TEST KIT | DHC | Substantially Equivalent | |
| K001398 | REAADS IGM ANTI-PROTHROMBIN SEMI-QUANTITATIVE TEST KIT | DHC | Substantially Equivalent | |
| K000920 | REAADS IGA ANTI-PHOSPHATIDYLSERINE SEMI-QUANTITATIVE TEST KIT | MID | Substantially Equivalent | |
| K983914 | REAADS MONOCLONAL FREE PROTEIN S ANTIGEN TEST KIT | GGP | Substantially Equivalent | |
| K982434 | REAADS IGA ANTI-B2GP 1 TEST KIT | MSV | Substantially Equivalent | |
| K982433 | REAADS IGM ANTI-B2GP1 TEST KIT | MSV | Substantially Equivalent | |
| K982391 | REAADS IGG ANTI-B2GPI TEST KIT | MSV | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1721937 | 1000117401 | CORGENIX, INC. | 11575 MAIN ST., BROOMFIELD, CO 80020 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- OBW11-Dehydro Thromboxane B2 Kit, Urinary
- LKJAntinuclear Antibody, Antigen, Control
- DHNAntinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
- GGCControl, Plasma, Abnormal
- OSXGalectin-3 In Vitro Diagnostic Assay
- GIZPlasma, Control, Normal
- OTVResearch Use Only/Clinical Chemistry Devices
- OTQResearch Use Only/Hematology Devices
- MIDSystem, Test, Anticardiolipin Immunological
- DHCSystem, Test, Systemic Lupus Erythematosus
- MSVSystem,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)
- GGPTest, Qualitative And Quantitative Factor Deficiency
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain