Company ยท US
Corgenix, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1998 to 2008. Name variants (Inc, Corp, punctuation) are merged.
23510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| MID | System, Test, Anticardiolipin Immunological | 8 |
| MSV | System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi) | 8 |
| DHC | System, Test, Systemic Lupus Erythematosus | 2 |
| GGP | Test, Qualitative And Quantitative Factor Deficiency | 2 |
| DHN | Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control | 1 |
| LKJ | Antinuclear Antibody, Antigen, Control | 1 |
| OBW | 11-Dehydro Thromboxane B2 Kit, Urinary | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 4, 2008 | K072032 | IGG ANTI-ATHEROX TEST KIT Corgenix, Inc. | MSV |
| May 29, 2007 | K062025 | ASPIRINWORKS TEST KIT (11-DEHYDRO THROMBOXANE B2), MODEL 12136 Corgenix, Inc. | OBW |
| Nov 19, 2004 | K042680 | RHIGENE HEP-ANA TEST SYSTEM Corgenix, Inc. | DHN |
| Apr 5, 2004 | K032139 | REAADS VON WILLEBRAND FACTOR ACTIVITY TEST KIT, MODEL 10826 Corgenix, Inc. | GGP |
| Jan 8, 2004 | K034013 | REAADS DSDNA QUANTITATIVE TEST KIT, MODEL 022-001 Corgenix, Inc. | LKJ |
| Oct 14, 2003 | K032868 | REAADS II ANTI-CARDIOLIPIN IGG SEMI-QUANTITATIVE TEST KIT, MODEL 11139 Corgenix, Inc. | MID |
| Jul 7, 2003 | K031208 | REAADS IGM ANTI-B2GPI TEST KIT, MODEL 038-001 Corgenix, Inc. | MSV |
| Jan 3, 2003 | K024196 | REEADS ANTI-PHOSPHATIDYLSERINE IGG/IGM SEMI-QUANTITATIVE TEST KIT Corgenix, Inc. | MID |
| Jan 3, 2003 | K024195 | MODIFICATION TO REAADS ANTI-PHOSPHATIDYLSERINE IGA SEMI-QUANTATIVE TEST KIT Corgenix, Inc. | MID |
| Sep 25, 2002 | K022992 | REAADS ANTI-CARDIOLIPIN IGG/IGM SEMI-QUANTITATIVE TEST KIT, MODEL 023-001 Corgenix, Inc. | MID |
| Sep 25, 2002 | K022990 | REAADS IGA ANTI-CARDIOLIPIN SEMI-QUANTITATIVE TEST KIT, MODEL 026-001 Corgenix, Inc. | MID |
| Sep 28, 2001 | K013080 | REAADS ANTI-BETA 2 GLYCOPROTEIN I IGG TEST KIT Corgenix, Inc. | MSV |
| Sep 28, 2001 | K013079 | REAADS ANTI-BETA 2 GLYCOPROTEIN I IGA TEST KIT Corgenix, Inc. | MSV |
| Sep 28, 2001 | K013077 | REAADS ANTI-BETA 2 GLYCOPROTEIN I IGM TEST KIT Corgenix, Inc. | MSV |
| Sep 20, 2001 | K013018 | REAADS ANTI-PHOSPHATIDYLSERINE IGA SEMI-QUANTITIVE TEST KIT Corgenix, Inc. | MID |
| Aug 23, 2001 | K012567 | MODIFICATION TO: REAADS ANTI-PHOSPHATIDYLSERINE IGG/IGM SEMI-QUANTITATIVE TEST KIT Corgenix, Inc. | MID |
| Apr 9, 2001 | K001352 | REAADS IGG ANTI-PROTHROMBIN SEMI-QUANTITATIVE TEST KIT Corgenix, Inc. | DHC |
| Mar 30, 2001 | K001398 | REAADS IGM ANTI-PROTHROMBIN SEMI-QUANTITATIVE TEST KIT Corgenix, Inc. | DHC |
| Apr 26, 2000 | K000920 | REAADS IGA ANTI-PHOSPHATIDYLSERINE SEMI-QUANTITATIVE TEST KIT Corgenix, Inc. | MID |
| Dec 22, 1998 | K983914 | REAADS MONOCLONAL FREE PROTEIN S ANTIGEN TEST KIT Corgenix, Inc. | GGP |
| Dec 22, 1998 | K982434 | REAADS IGA ANTI-B2GP 1 TEST KIT Corgenix, Inc. | MSV |
| Dec 7, 1998 | K982433 | REAADS IGM ANTI-B2GP1 TEST KIT Corgenix, Inc. | MSV |
| Dec 7, 1998 | K982391 | REAADS IGG ANTI-B2GPI TEST KIT Corgenix, Inc. | MSV |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||