Corgenix, Inc. - FDA 510(k) Cleared Devices
23
Total
23
Cleared
0
Denied
FDA 510(k) Regulatory Record - Corgenix, Inc. Immunology ✕
20 devices
Cleared
Apr 04, 2008
IGG ANTI-ATHEROX TEST KIT
Immunology
255d
Cleared
Nov 19, 2004
RHIGENE HEP-ANA TEST SYSTEM
Immunology
51d
Cleared
Jan 08, 2004
REAADS DSDNA QUANTITATIVE TEST KIT, MODEL 022-001
Immunology
15d
Cleared
Oct 14, 2003
REAADS II ANTI-CARDIOLIPIN IGG SEMI-QUANTITATIVE TEST KIT, MODEL 11139
Immunology
29d
Cleared
Jul 07, 2003
REAADS IGM ANTI-B2GPI TEST KIT, MODEL 038-001
Immunology
81d
Cleared
Jan 03, 2003
MODIFICATION TO REAADS ANTI-PHOSPHATIDYLSERINE IGA SEMI-QUANTATIVE TEST KIT
Immunology
14d
Cleared
Jan 03, 2003
REEADS ANTI-PHOSPHATIDYLSERINE IGG/IGM SEMI-QUANTITATIVE TEST KIT
Immunology
14d
Cleared
Sep 25, 2002
REAADS IGA ANTI-CARDIOLIPIN SEMI-QUANTITATIVE TEST KIT, MODEL 026-001
Immunology
16d
Cleared
Sep 25, 2002
REAADS ANTI-CARDIOLIPIN IGG/IGM SEMI-QUANTITATIVE TEST KIT, MODEL 023-001
Immunology
16d
Cleared
Sep 28, 2001
REAADS ANTI-BETA 2 GLYCOPROTEIN I IGM TEST KIT
Immunology
14d
Cleared
Sep 28, 2001
REAADS ANTI-BETA 2 GLYCOPROTEIN I IGA TEST KIT
Immunology
14d
Cleared
Sep 28, 2001
REAADS ANTI-BETA 2 GLYCOPROTEIN I IGG TEST KIT
Immunology
14d
Cleared
Sep 20, 2001
REAADS ANTI-PHOSPHATIDYLSERINE IGA SEMI-QUANTITIVE TEST KIT
Immunology
13d
Cleared
Aug 23, 2001
MODIFICATION TO: REAADS ANTI-PHOSPHATIDYLSERINE IGG/IGM SEMI-QUANTITATIVE...
Immunology
14d
Cleared
Apr 09, 2001
REAADS IGG ANTI-PROTHROMBIN SEMI-QUANTITATIVE TEST KIT
Immunology
346d
Cleared
Mar 30, 2001
REAADS IGM ANTI-PROTHROMBIN SEMI-QUANTITATIVE TEST KIT
Immunology
331d
Cleared
Apr 26, 2000
REAADS IGA ANTI-PHOSPHATIDYLSERINE SEMI-QUANTITATIVE TEST KIT
Immunology
35d
Cleared
Dec 22, 1998
REAADS IGA ANTI-B2GP 1 TEST KIT
Immunology
161d
Cleared
Dec 07, 1998
REAADS IGG ANTI-B2GPI TEST KIT
Immunology
151d
Cleared
Dec 07, 1998
REAADS IGM ANTI-B2GP1 TEST KIT
Immunology
146d