DHC · Class II · 21 CFR 866.5820

FDA Product Code DHC: System, Test, Systemic Lupus Erythematosus

Leading manufacturers include Corgenix, Inc., Icl Scientific and Cordis Corp..

16
Total
16
Cleared
71d
Avg days
1979
Since

FDA 510(k) Cleared System, Test, Systemic Lupus Erythematosus Devices (Product Code DHC)

16 devices
1–16 of 16
Cleared Apr 09, 2001
REAADS IGG ANTI-PROTHROMBIN SEMI-QUANTITATIVE TEST KIT
K001352
Corgenix, Inc.
Immunology · 346d
Cleared Mar 30, 2001
REAADS IGM ANTI-PROTHROMBIN SEMI-QUANTITATIVE TEST KIT
K001398
Corgenix, Inc.
Immunology · 331d
Cleared Mar 10, 1993
HUMAN A-DS DNA EIA KIT FOR DIAGNOSTIC USE
K930247
The Binding Site, Ltd.
Immunology · 50d
Cleared Mar 10, 1993
ELIAS DSDNA ABS
K930421
Elias U.S.A., Inc.
Immunology · 43d
Cleared Dec 09, 1991
IMMUNOWELL DSDNA ANTIBODY TEST
K914801
General Biometrics, Inc.
Immunology · 46d
Cleared May 28, 1982
SERO/TEX LE TEST
K821385
Texas Immunology, Inc.
Immunology · 18d
Cleared Feb 09, 1981
SLE ANTI-N-DNA LATEX TEST
K810226
Icl Scientific
Immunology · 13d
Cleared May 08, 1980
CORDIA N
K800991
Cordis Corp.
Immunology · 14d
Cleared May 08, 1980
CORDIA NP
K800992
Cordis Corp.
Immunology · 14d
Cleared Mar 15, 1979
IIF-A-N-DNA TEST KIT
K790106
Medica Corp.
Immunology · 56d
Cleared Mar 15, 1979
SYSTEMIC LUPUS
K790257
Icl Scientific
Immunology · 37d
Cleared Mar 12, 1979
LUPO-TEC
K782129
Armkel, LLC
Immunology · 75d

About Product Code DHC - Regulatory Context