Medical Device Manufacturer · US , Westminster , CO

Corgenix, Inc. - FDA 510(k) Cleared Devices

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

Corgenix, Inc. has 23 FDA 510(k) cleared immunology devices. Based in Westminster, US.

Historical record: 23 cleared submissions from 1998 to 2008.

Browse the complete list of FDA 510(k) cleared immunology devices from this manufacturer. Filter by specialty or product code using the sidebar.

FDA 510(k) Regulatory Record - Corgenix, Inc.

23 devices
1-23 of 23
Cleared Apr 04, 2008
IGG ANTI-ATHEROX TEST KIT
K072032 · MSV
Immunology · 255d
Cleared May 29, 2007
ASPIRINWORKS TEST KIT (11-DEHYDRO THROMBOXANE B2), MODEL 12136
K062025 · OBW
Hematology · 315d
Cleared Nov 19, 2004
RHIGENE HEP-ANA TEST SYSTEM
K042680 · DHN
Immunology · 51d
Cleared Apr 05, 2004
REAADS VON WILLEBRAND FACTOR ACTIVITY TEST KIT, MODEL 10826
K032139 · GGP
Hematology · 269d
Cleared Jan 08, 2004
REAADS DSDNA QUANTITATIVE TEST KIT, MODEL 022-001
K034013 · LKJ
Immunology · 15d
Cleared Oct 14, 2003
REAADS II ANTI-CARDIOLIPIN IGG SEMI-QUANTITATIVE TEST KIT, MODEL 11139
K032868 · MID
Immunology · 29d
Cleared Jul 07, 2003
REAADS IGM ANTI-B2GPI TEST KIT, MODEL 038-001
K031208 · MSV
Immunology · 81d
Cleared Jan 03, 2003
MODIFICATION TO REAADS ANTI-PHOSPHATIDYLSERINE IGA SEMI-QUANTATIVE TEST KIT
K024195 · MID
Immunology · 14d
Cleared Jan 03, 2003
REEADS ANTI-PHOSPHATIDYLSERINE IGG/IGM SEMI-QUANTITATIVE TEST KIT
K024196 · MID
Immunology · 14d
Cleared Sep 25, 2002
REAADS IGA ANTI-CARDIOLIPIN SEMI-QUANTITATIVE TEST KIT, MODEL 026-001
K022990 · MID
Immunology · 16d
Cleared Sep 25, 2002
REAADS ANTI-CARDIOLIPIN IGG/IGM SEMI-QUANTITATIVE TEST KIT, MODEL 023-001
K022992 · MID
Immunology · 16d
Cleared Sep 28, 2001
REAADS ANTI-BETA 2 GLYCOPROTEIN I IGM TEST KIT
K013077 · MSV
Immunology · 14d
Cleared Sep 28, 2001
REAADS ANTI-BETA 2 GLYCOPROTEIN I IGA TEST KIT
K013079 · MSV
Immunology · 14d
Cleared Sep 28, 2001
REAADS ANTI-BETA 2 GLYCOPROTEIN I IGG TEST KIT
K013080 · MSV
Immunology · 14d
Cleared Sep 20, 2001
REAADS ANTI-PHOSPHATIDYLSERINE IGA SEMI-QUANTITIVE TEST KIT
K013018 · MID
Immunology · 13d
Cleared Aug 23, 2001
MODIFICATION TO: REAADS ANTI-PHOSPHATIDYLSERINE IGG/IGM SEMI-QUANTITATIVE...
K012567 · MID
Immunology · 14d
Cleared Apr 09, 2001
REAADS IGG ANTI-PROTHROMBIN SEMI-QUANTITATIVE TEST KIT
K001352 · DHC
Immunology · 346d
Cleared Mar 30, 2001
REAADS IGM ANTI-PROTHROMBIN SEMI-QUANTITATIVE TEST KIT
K001398 · DHC
Immunology · 331d
Cleared Apr 26, 2000
REAADS IGA ANTI-PHOSPHATIDYLSERINE SEMI-QUANTITATIVE TEST KIT
K000920 · MID
Immunology · 35d
Cleared Dec 22, 1998
REAADS IGA ANTI-B2GP 1 TEST KIT
K982434 · MSV
Immunology · 161d
Cleared Dec 22, 1998
REAADS MONOCLONAL FREE PROTEIN S ANTIGEN TEST KIT
K983914 · GGP
Hematology · 48d
Cleared Dec 07, 1998
REAADS IGG ANTI-B2GPI TEST KIT
K982391 · MSV
Immunology · 151d
Cleared Dec 07, 1998
REAADS IGM ANTI-B2GP1 TEST KIT
K982433 · MSV
Immunology · 146d
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