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510(k) K001352

Device
REAADS IGG ANTI-PROTHROMBIN SEMI-QUANTITATIVE TEST KIT
Applicant
Corgenix, Inc.
510(k) number
K001352
Product code
DHC
Decision
Substantially Equivalent (SESE)
Decision date
2001-04-09
Date received
2000-04-28
Regulation
866.5820
Classification name
System, Test, Systemic Lupus Erythematosus
Medical specialty
Immunology
Review panel
Immunology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
NANCI DEXTER
Address
12061 Tejon St. Westminster CO US 80234 80234

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code DHC#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K001398REAADS IGM ANTI-PROTHROMBIN SEMI-QUANTITATIVE TEST KITCorgenix, Inc.2001-03-30
K930247HUMAN A-DS DNA EIA KIT FOR DIAGNOSTIC USEThe Binding Site, Ltd.1993-03-10
K930421ELIAS DSDNA ABSElias U.S.A., Inc.1993-03-10
K914801IMMUNOWELL DSDNA ANTIBODY TESTGeneral Biometrics, Inc.1991-12-09
K885048ACCESS R-CLONE ANA PROFILE ASSAYLipogen, Inc.1989-01-24
K872910IMMUNO/SLEImmunostics Co., Inc.1987-08-12
K821385SERO/TEX LE TESTTexas Immunology, Inc.1982-05-28
K810981ANTI NDNA IMMUNOFLOURESCENT TEST SYSImmuno-Products Industries1981-04-29
K810226SLE ANTI-N-DNA LATEX TESTIcl Scientific1981-02-09
K800991CORDIA NCordis Corp.1980-05-08
K800992CORDIA NPCordis Corp.1980-05-08
K800605ANA LATEX SLIDE TESTBiologics Intl., Inc.1980-04-02
K790106IIF-A-N-DNA TEST KITMedica Corp.1979-03-15
K790257SYSTEMIC LUPUSIcl Scientific1979-03-15
K782129LUPO-TECArmkel, LLC1979-03-12