FDA 510(k) Applications for Medical Device Product Code "DHC"
(System, Test, Systemic Lupus Erythematosus)

FDA 510(k) Number Applicant Device Name Decision Date
K782129 ARMKEL, LLC. LUPO-TEC 03/12/1979
K800605 BIOLOGICS INTL., INC. ANA LATEX SLIDE TEST 04/02/1980
K800991 CORDIS CORP. CORDIA N 05/08/1980
K800992 CORDIS CORP. CORDIA NP 05/08/1980
K001352 CORGENIX, INC. REAADS IGG ANTI-PROTHROMBIN SEMI-QUANTITATIVE TEST KIT 04/09/2001
K001398 CORGENIX, INC. REAADS IGM ANTI-PROTHROMBIN SEMI-QUANTITATIVE TEST KIT 03/30/2001
K930421 ELIAS USA, INC. ELIAS DSDNA ABS 03/10/1993
K914801 GENERAL BIOMETRICS, INC. IMMUNOWELL DSDNA ANTIBODY TEST 12/09/1991
K810226 ICL SCIENTIFIC SLE ANTI-N-DNA LATEX TEST 02/09/1981
K790257 ICL SCIENTIFIC SYSTEMIC LUPUS 03/15/1979
K810981 IMMUNO-PRODUCTS INDUSTRIES ANTI NDNA IMMUNOFLOURESCENT TEST SYS 04/29/1981
K872910 IMMUNOSTICS CO., INC. IMMUNO/SLE 08/12/1987
K885048 LIPOGEN, INC. ACCESS R-CLONE ANA PROFILE ASSAY 01/24/1989
K790106 MEDICA CORP. IIF-A-N-DNA TEST KIT 03/15/1979
K821385 TEXAS IMMUNOLOGY, INC. SERO/TEX LE TEST 05/28/1982
K930247 THE BINDING SITE, LTD. HUMAN A-DS DNA EIA KIT FOR DIAGNOSTIC USE 03/10/1993


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