Medical Device Manufacturer · US , Westminster , CO

Corgenix, Inc.

23 submissions · 23 cleared · Since 1998
23
Total
23
Cleared
0
Denied

Corgenix, Inc. — FDA 510(k) Submissions

Corgenix, Inc. has submitted 23 FDA 510(k) premarket notifications since 1998, of which 23 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include System, Test, Anticardiolipin Immunological, System,test,antibodies,b2 - Glycoprotein I (b2 - Gpi), System, Test, Systemic Lupus Erythematosus, Test, Qualitative And Quantitative Factor Deficiency, Antinuclear Antibody, Antigen, Control . Use the specialty filter in the sidebar to narrow results.

23 devices
1–23 of 23
IGG ANTI-ATHEROX TEST KIT
K072032 · MSV System,test,antibodies,b2... · Immunology
Apr 2008 255d
ASPIRINWORKS TEST KIT (11-DEHYDRO THROMBOXANE B2), MODEL 12136
K062025 · OBW 11-dehydro Thromboxane B2... · Hematology
May 2007 315d
RHIGENE HEP-ANA TEST SYSTEM
K042680 · DHN Antinuclear Antibody,... · Immunology
Nov 2004 51d
REAADS VON WILLEBRAND FACTOR ACTIVITY TEST KIT, MODEL 10826
K032139 · GGP Test, Qualitative And... · Hematology
Apr 2004 269d
REAADS DSDNA QUANTITATIVE TEST KIT, MODEL 022-001
K034013 · LKJ Antinuclear Antibody,... · Immunology
Jan 2004 15d
REAADS II ANTI-CARDIOLIPIN IGG SEMI-QUANTITATIVE TEST KIT, MODEL 11139
K032868 · MID System, Test,... · Immunology
Oct 2003 29d
REAADS IGM ANTI-B2GPI TEST KIT, MODEL 038-001
K031208 · MSV System,test,antibodies,b2... · Immunology
Jul 2003 81d
MODIFICATION TO REAADS ANTI-PHOSPHATIDYLSERINE IGA SEMI-QUANTATIVE TEST KIT
K024195 · MID System, Test,... · Immunology
Jan 2003 14d
REEADS ANTI-PHOSPHATIDYLSERINE IGG/IGM SEMI-QUANTITATIVE TEST KIT
K024196 · MID System, Test,... · Immunology
Jan 2003 14d
REAADS IGA ANTI-CARDIOLIPIN SEMI-QUANTITATIVE TEST KIT, MODEL 026-001
K022990 · MID System, Test,... · Immunology
Sep 2002 16d
REAADS ANTI-CARDIOLIPIN IGG/IGM SEMI-QUANTITATIVE TEST KIT, MODEL 023-001
K022992 · MID System, Test,... · Immunology
Sep 2002 16d
REAADS ANTI-BETA 2 GLYCOPROTEIN I IGM TEST KIT
K013077 · MSV System,test,antibodies,b2... · Immunology
Sep 2001 14d
REAADS ANTI-BETA 2 GLYCOPROTEIN I IGA TEST KIT
K013079 · MSV System,test,antibodies,b2... · Immunology
Sep 2001 14d
REAADS ANTI-BETA 2 GLYCOPROTEIN I IGG TEST KIT
K013080 · MSV System,test,antibodies,b2... · Immunology
Sep 2001 14d
REAADS ANTI-PHOSPHATIDYLSERINE IGA SEMI-QUANTITIVE TEST KIT
K013018 · MID System, Test,... · Immunology
Sep 2001 13d
MODIFICATION TO: REAADS ANTI-PHOSPHATIDYLSERINE IGG/IGM SEMI-QUANTITATIVE TEST KIT
K012567 · MID System, Test,... · Immunology
Aug 2001 14d
REAADS IGG ANTI-PROTHROMBIN SEMI-QUANTITATIVE TEST KIT
K001352 · DHC System, Test, Systemic... · Immunology
Apr 2001 346d
REAADS IGM ANTI-PROTHROMBIN SEMI-QUANTITATIVE TEST KIT
K001398 · DHC System, Test, Systemic... · Immunology
Mar 2001 331d
REAADS IGA ANTI-PHOSPHATIDYLSERINE SEMI-QUANTITATIVE TEST KIT
K000920 · MID System, Test,... · Immunology
Apr 2000 35d
REAADS IGA ANTI-B2GP 1 TEST KIT
K982434 · MSV System,test,antibodies,b2... · Immunology
Dec 1998 161d
REAADS MONOCLONAL FREE PROTEIN S ANTIGEN TEST KIT
K983914 · GGP Test, Qualitative And... · Hematology
Dec 1998 48d
REAADS IGG ANTI-B2GPI TEST KIT
K982391 · MSV System,test,antibodies,b2... · Immunology
Dec 1998 151d
REAADS IGM ANTI-B2GP1 TEST KIT
K982433 · MSV System,test,antibodies,b2... · Immunology
Dec 1998 146d
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