Corgenix, Inc.

FDA 510(k) & PMA Approved Devices — 23 products

Total Devices23

Categories0

Latest FDA decision

Type	Number	Device Name	Code	Date	Actions
510(k)	K072032	IGG ANTI-ATHEROX TEST KIT	MSV	2008-04-04	View
510(k)	K062025	ASPIRINWORKS TEST KIT (11-DEHYDRO THROMBOXANE B2), MODEL 12136	OBW	2007-05-29	View
510(k)	K042680	RHIGENE HEP-ANA TEST SYSTEM	DHN	2004-11-19	View
510(k)	K032139	REAADS VON WILLEBRAND FACTOR ACTIVITY TEST KIT, MODEL 10826	GGP	2004-04-05	View
510(k)	K034013	REAADS DSDNA QUANTITATIVE TEST KIT, MODEL 022-001	LKJ	2004-01-08	View
510(k)	K032868	REAADS II ANTI-CARDIOLIPIN IGG SEMI-QUANTITATIVE TEST KIT, MODEL 11139	MID	2003-10-14	View
510(k)	K031208	REAADS IGM ANTI-B2GPI TEST KIT, MODEL 038-001	MSV	2003-07-07	View
510(k)	K024195	MODIFICATION TO REAADS ANTI-PHOSPHATIDYLSERINE IGA SEMI-QUANTATIVE TEST KIT	MID	2003-01-03	View
510(k)	K024196	REEADS ANTI-PHOSPHATIDYLSERINE IGG/IGM SEMI-QUANTITATIVE TEST KIT	MID	2003-01-03	View
510(k)	K022992	REAADS ANTI-CARDIOLIPIN IGG/IGM SEMI-QUANTITATIVE TEST KIT, MODEL 023-001	MID	2002-09-25	View
510(k)	K022990	REAADS IGA ANTI-CARDIOLIPIN SEMI-QUANTITATIVE TEST KIT, MODEL 026-001	MID	2002-09-25	View
510(k)	K013077	REAADS ANTI-BETA 2 GLYCOPROTEIN I IGM TEST KIT	MSV	2001-09-28	View
510(k)	K013080	REAADS ANTI-BETA 2 GLYCOPROTEIN I IGG TEST KIT	MSV	2001-09-28	View
510(k)	K013079	REAADS ANTI-BETA 2 GLYCOPROTEIN I IGA TEST KIT	MSV	2001-09-28	View
510(k)	K013018	REAADS ANTI-PHOSPHATIDYLSERINE IGA SEMI-QUANTITIVE TEST KIT	MID	2001-09-20	View
510(k)	K012567	MODIFICATION TO: REAADS ANTI-PHOSPHATIDYLSERINE IGG/IGM SEMI-QUANTITATIVE TEST KIT	MID	2001-08-23	View
510(k)	K001352	REAADS IGG ANTI-PROTHROMBIN SEMI-QUANTITATIVE TEST KIT	DHC	2001-04-09	View
510(k)	K001398	REAADS IGM ANTI-PROTHROMBIN SEMI-QUANTITATIVE TEST KIT	DHC	2001-03-30	View
510(k)	K000920	REAADS IGA ANTI-PHOSPHATIDYLSERINE SEMI-QUANTITATIVE TEST KIT	MID	2000-04-26	View
510(k)	K982434	REAADS IGA ANTI-B2GP 1 TEST KIT	MSV	1998-12-22	View