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Corgenix, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
23
Inspections
1
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K072032IGG ANTI-ATHEROX TEST KITApril 4, 2008
K062025ASPIRINWORKS TEST KIT (11-DEHYDRO THROMBOXANE B2), MODEL 12136May 29, 2007
K042680RHIGENE HEP-ANA TEST SYSTEMNovember 19, 2004
K032139REAADS VON WILLEBRAND FACTOR ACTIVITY TEST KIT, MODEL 10826April 5, 2004
K034013REAADS DSDNA QUANTITATIVE TEST KIT, MODEL 022-001January 8, 2004
K032868REAADS II ANTI-CARDIOLIPIN IGG SEMI-QUANTITATIVE TEST KIT, MODEL 11139October 14, 2003
K031208REAADS IGM ANTI-B2GPI TEST KIT, MODEL 038-001July 7, 2003
K024196REEADS ANTI-PHOSPHATIDYLSERINE IGG/IGM SEMI-QUANTITATIVE TEST KITJanuary 3, 2003
K024195MODIFICATION TO REAADS ANTI-PHOSPHATIDYLSERINE IGA SEMI-QUANTATIVE TEST KITJanuary 3, 2003
K022992REAADS ANTI-CARDIOLIPIN IGG/IGM SEMI-QUANTITATIVE TEST KIT, MODEL 023-001September 25, 2002
K022990REAADS IGA ANTI-CARDIOLIPIN SEMI-QUANTITATIVE TEST KIT, MODEL 026-001September 25, 2002
K013080REAADS ANTI-BETA 2 GLYCOPROTEIN I IGG TEST KITSeptember 28, 2001
K013079REAADS ANTI-BETA 2 GLYCOPROTEIN I IGA TEST KITSeptember 28, 2001
K013077REAADS ANTI-BETA 2 GLYCOPROTEIN I IGM TEST KITSeptember 28, 2001
K013018REAADS ANTI-PHOSPHATIDYLSERINE IGA SEMI-QUANTITIVE TEST KITSeptember 20, 2001
K012567MODIFICATION TO: REAADS ANTI-PHOSPHATIDYLSERINE IGG/IGM SEMI-QUANTITATIVE TEST KITAugust 23, 2001
K001352REAADS IGG ANTI-PROTHROMBIN SEMI-QUANTITATIVE TEST KITApril 9, 2001
K001398REAADS IGM ANTI-PROTHROMBIN SEMI-QUANTITATIVE TEST KITMarch 30, 2001
K000920REAADS IGA ANTI-PHOSPHATIDYLSERINE SEMI-QUANTITATIVE TEST KITApril 26, 2000
K983914REAADS MONOCLONAL FREE PROTEIN S ANTIGEN TEST KITDecember 22, 1998