Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Corgenix, Inc. — Predicate Candidate Screening

23 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

35 daysmedian FDA review time

315 days90th percentile

23clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K072032	IGG ANTI-ATHEROX TEST KIT	Corgenix, Inc.	2008-04-04	255	0
K062025	ASPIRINWORKS TEST KIT (11-DEHYDRO THROMBOXANE B2), MODEL 121	Corgenix, Inc.	2007-05-29	315	0
K042680	RHIGENE HEP-ANA TEST SYSTEM	Corgenix, Inc.	2004-11-19	51	0
K032139	REAADS VON WILLEBRAND FACTOR ACTIVITY TEST KIT, MODEL 10826	Corgenix, Inc.	2004-04-05	269	0
K034013	REAADS DSDNA QUANTITATIVE TEST KIT, MODEL 022-001	Corgenix, Inc.	2004-01-08	15	0
K032868	REAADS II ANTI-CARDIOLIPIN IGG SEMI-QUANTITATIVE TEST KIT, M	Corgenix, Inc.	2003-10-14	29	1
K031208	REAADS IGM ANTI-B2GPI TEST KIT, MODEL 038-001	Corgenix, Inc.	2003-07-07	81	0
K024195	MODIFICATION TO REAADS ANTI-PHOSPHATIDYLSERINE IGA SEMI-QUAN	Corgenix, Inc.	2003-01-03	14	0
K024196	REEADS ANTI-PHOSPHATIDYLSERINE IGG/IGM SEMI-QUANTITATIVE TES	Corgenix, Inc.	2003-01-03	14	0
K022992	REAADS ANTI-CARDIOLIPIN IGG/IGM SEMI-QUANTITATIVE TEST KIT,	Corgenix, Inc.	2002-09-25	16	0
K022990	REAADS IGA ANTI-CARDIOLIPIN SEMI-QUANTITATIVE TEST KIT, MODE	Corgenix, Inc.	2002-09-25	16	0
K013080	REAADS ANTI-BETA 2 GLYCOPROTEIN I IGG TEST KIT	Corgenix, Inc.	2001-09-28	14	0
K013079	REAADS ANTI-BETA 2 GLYCOPROTEIN I IGA TEST KIT	Corgenix, Inc.	2001-09-28	14	0
K013077	REAADS ANTI-BETA 2 GLYCOPROTEIN I IGM TEST KIT	Corgenix, Inc.	2001-09-28	14	0
K013018	REAADS ANTI-PHOSPHATIDYLSERINE IGA SEMI-QUANTITIVE TEST KIT	Corgenix, Inc.	2001-09-20	13	0
K012567	MODIFICATION TO: REAADS ANTI-PHOSPHATIDYLSERINE IGG/IGM SEMI	Corgenix, Inc.	2001-08-23	14	0
K001352	REAADS IGG ANTI-PROTHROMBIN SEMI-QUANTITATIVE TEST KIT	Corgenix, Inc.	2001-04-09	346	0
K001398	REAADS IGM ANTI-PROTHROMBIN SEMI-QUANTITATIVE TEST KIT	Corgenix, Inc.	2001-03-30	331	0
K000920	REAADS IGA ANTI-PHOSPHATIDYLSERINE SEMI-QUANTITATIVE TEST KI	Corgenix, Inc.	2000-04-26	35	0
K982434	REAADS IGA ANTI-B2GP 1 TEST KIT	Corgenix, Inc.	1998-12-22	161	0
K983914	REAADS MONOCLONAL FREE PROTEIN S ANTIGEN TEST KIT	Corgenix, Inc.	1998-12-22	48	0
K982391	REAADS IGG ANTI-B2GPI TEST KIT	Corgenix, Inc.	1998-12-07	151	0
K982433	REAADS IGM ANTI-B2GP1 TEST KIT	Corgenix, Inc.	1998-12-07	146	0

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda