FDA 510(k) Applications Submitted by CORGENIX, INC.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K072032 |
07/24/2007 |
IGG ANTI-ATHEROX TEST KIT |
CORGENIX, INC. |
| K062025 |
07/18/2006 |
ASPIRINWORKS TEST KIT (11-DEHYDRO THROMBOXANE B2), MODEL 12136 |
CORGENIX, INC. |
| K000920 |
03/22/2000 |
REAADS IGA ANTI-PHOSPHATIDYLSERINE SEMI-QUANTITATIVE TEST KIT |
CORGENIX, INC. |
| K031208 |
04/17/2003 |
REAADS IGM ANTI-B2GPI TEST KIT, MODEL 038-001 |
CORGENIX, INC. |
| K001352 |
04/28/2000 |
REAADS IGG ANTI-PROTHROMBIN SEMI-QUANTITATIVE TEST KIT |
CORGENIX, INC. |
| K001398 |
05/03/2000 |
REAADS IGM ANTI-PROTHROMBIN SEMI-QUANTITATIVE TEST KIT |
CORGENIX, INC. |
| K982391 |
07/09/1998 |
REAADS IGG ANTI-B2GPI TEST KIT |
CORGENIX, INC. |
| K032139 |
07/11/2003 |
REAADS VON WILLEBRAND FACTOR ACTIVITY TEST KIT, MODEL 10826 |
CORGENIX, INC. |
| K982433 |
07/14/1998 |
REAADS IGM ANTI-B2GP1 TEST KIT |
CORGENIX, INC. |
| K982434 |
07/14/1998 |
REAADS IGA ANTI-B2GP 1 TEST KIT |
CORGENIX, INC. |
| K012567 |
08/09/2001 |
MODIFICATION TO: REAADS ANTI-PHOSPHATIDYLSERINE IGG/IGM SEMI-QUANTITATIVE TEST KIT |
CORGENIX, INC. |
| K013018 |
09/07/2001 |
REAADS ANTI-PHOSPHATIDYLSERINE IGA SEMI-QUANTITIVE TEST KIT |
CORGENIX, INC. |
| K022990 |
09/09/2002 |
REAADS IGA ANTI-CARDIOLIPIN SEMI-QUANTITATIVE TEST KIT, MODEL 026-001 |
CORGENIX, INC. |
| K022992 |
09/09/2002 |
REAADS ANTI-CARDIOLIPIN IGG/IGM SEMI-QUANTITATIVE TEST KIT, MODEL 023-001 |
CORGENIX, INC. |
| K013077 |
09/14/2001 |
REAADS ANTI-BETA 2 GLYCOPROTEIN I IGM TEST KIT |
CORGENIX, INC. |
| K013079 |
09/14/2001 |
REAADS ANTI-BETA 2 GLYCOPROTEIN I IGA TEST KIT |
CORGENIX, INC. |
| K013080 |
09/14/2001 |
REAADS ANTI-BETA 2 GLYCOPROTEIN I IGG TEST KIT |
CORGENIX, INC. |
| K032868 |
09/15/2003 |
REAADS II ANTI-CARDIOLIPIN IGG SEMI-QUANTITATIVE TEST KIT, MODEL 11139 |
CORGENIX, INC. |
| K983914 |
11/04/1998 |
REAADS MONOCLONAL FREE PROTEIN S ANTIGEN TEST KIT |
CORGENIX, INC. |
| K024195 |
12/20/2002 |
MODIFICATION TO REAADS ANTI-PHOSPHATIDYLSERINE IGA SEMI-QUANTATIVE TEST KIT |
CORGENIX, INC. |
| K024196 |
12/20/2002 |
REEADS ANTI-PHOSPHATIDYLSERINE IGG/IGM SEMI-QUANTITATIVE TEST KIT |
CORGENIX, INC. |
| K034013 |
12/24/2003 |
REAADS DSDNA QUANTITATIVE TEST KIT, MODEL 022-001 |
CORGENIX, INC. |
| K042680 |
09/29/2004 |
RHIGENE HEP-ANA TEST SYSTEM |
CORGENIX, INC. |
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