Data / Medical devices / United States / Corgenix, Inc.

Corgenix, Inc.: FDA-registered device maker in Broomfield, CO, United States, 16 510(k) clearances

Name: Corgenix, Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Corgenix, Inc. is registered with the FDA (registration 1721937) in Broomfield, CO, United States. It lists 10 device types. The FDA files 16 510(k) clearances under its listings, the newest dated December 15, 2010. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this one Watch Corgenix, Inc.

FDA registration number: 1721937
FEI number: 1000117401
Address: 11575 Main ST. Suite 400, Broomfield, CO, United States, 80020
Owner or operator: CORGENIX, INC. (9001900)
Roles: Contract manufacturer, Manufacturer, Manufacturer for export, Repackager or relabeler
First device listed: June 4, 2007
Registered through: 2026
Brand names listed: Anti IL-23 ELISA Test Kit, Anti VEGF-D ELISA Test KIt, Anti-AtherOx IgG Test Kit (IgG anti-oxLDL-B2GPI), Corgenix 11dhTxB2 Test Kit, Corgenix Anti-Beta-2 Glycoprotein IgA Semi-Quantitative Test Kit, Corgenix AspirinWorks Test Kit, Corgenix Collagen Binding Assay, Corgenix HA ELISA Test Kit and more

Devices it lists

Device	Product code	Class	Role	Source
11-Dehydro Thromboxane B2 Kit, Urinary	OBW	2	Contract manufacturer, Manufacturer, Repackager or relabeler	accessdata.fda.gov
Control, Plasma, Abnormal	GGC	2	Repackager or relabeler	accessdata.fda.gov
Galectin-3 In Vitro Diagnostic Assay	OSX	2	Manufacturer	accessdata.fda.gov
Plasma, Control, Normal	GIZ	2	Repackager or relabeler	accessdata.fda.gov
Research Use Only/Clinical Chemistry Devices	OTV	N	Manufacturer for export	accessdata.fda.gov
Research Use Only/Hematology Devices	OTQ	N	Manufacturer for export	accessdata.fda.gov
System, Test, Anticardiolipin Immunological	MID	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
System, Test, Systemic Lupus Erythematosus	DHC	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)	MSV	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Test, Qualitative And Quantitative Factor Deficiency	GGP	2	Manufacturer, Manufacturer for export	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
December 15, 2010	K100103	SPECIALTY ASSAYED CONTROL-2	GGC	Substantially Equivalent	Helena Laboratories	accessdata.fda.gov
November 17, 2010	K093758	BGM GALECTIN -3	OSX	Substantially Equivalent	Bg Medicine, Inc.	accessdata.fda.gov
April 4, 2008	K072032	IGG ANTI-ATHEROX TEST KIT	MSV	Substantially Equivalent	Corgenix, Inc.	accessdata.fda.gov
May 29, 2007	K062025	ASPIRINWORKS TEST KIT (11-DEHYDRO THROMBOXANE B2), MODEL 12136	OBW	Substantially Equivalent	Corgenix, Inc.	accessdata.fda.gov
April 5, 2004	K032139	REAADS VON WILLEBRAND FACTOR ACTIVITY TEST KIT, MODEL 10826	GGP	Substantially Equivalent	Corgenix, Inc.	accessdata.fda.gov
October 14, 2003	K032868	REAADS II ANTI-CARDIOLIPIN IGG SEMI-QUANTITATIVE TEST KIT, MODEL 11139	MID	Substantially Equivalent	Corgenix, Inc.	accessdata.fda.gov
July 7, 2003	K031208	REAADS IGM ANTI-B2GPI TEST KIT, MODEL 038-001	MSV	Substantially Equivalent	Corgenix, Inc.	accessdata.fda.gov
January 3, 2003	K024196	REEADS ANTI-PHOSPHATIDYLSERINE IGG/IGM SEMI-QUANTITATIVE TEST KIT	MID	Substantially Equivalent	Corgenix, Inc.	accessdata.fda.gov
January 3, 2003	K024195	MODIFICATION TO REAADS ANTI-PHOSPHATIDYLSERINE IGA SEMI-QUANTATIVE TEST KIT	MID	Substantially Equivalent	Corgenix, Inc.	accessdata.fda.gov
September 25, 2002	K022992	REAADS ANTI-CARDIOLIPIN IGG/IGM SEMI-QUANTITATIVE TEST KIT, MODEL 023-001	MID	Substantially Equivalent	Corgenix, Inc.	accessdata.fda.gov
September 25, 2002	K022990	REAADS IGA ANTI-CARDIOLIPIN SEMI-QUANTITATIVE TEST KIT, MODEL 026-001	MID	Substantially Equivalent	Corgenix, Inc.	accessdata.fda.gov
December 22, 1998	K983914	REAADS MONOCLONAL FREE PROTEIN S ANTIGEN TEST KIT	GGP	Substantially Equivalent	Corgenix, Inc.	accessdata.fda.gov
October 6, 1997	K972342	REAADS PROTEIN C ANTIGEN TEST KIT	GGP	Substantially Equivalent	Reaads Medical Products, Inc.	accessdata.fda.gov
August 13, 1997	K972482	REAADS PROTEIN S ANTIGEN TEST KIT	GGP	Substantially Equivalent	Reaads Medical Products, Inc.	accessdata.fda.gov
August 13, 1997	K972005	REAADS VON WILLEBRAND FACTOR ANTIGEN TEST KIT	GGP	Substantially Equivalent	Reaads Medical Products, Inc.	accessdata.fda.gov
October 7, 1994	K941737	SPECIALTY ASSAYED CONTROL-1	GIZ	Substantially Equivalent	Helena Laboratories	accessdata.fda.gov

Compare with other makers

Updated December 15, 2010. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.