FDA 510(k) Applications for Medical Device Product Code "DGC"
(Ige, Antigen, Antiserum, Control)

FDA 510(k) Number Applicant Device Name Decision Date
K900108 3M COMPANY 3M MULTI-ALLER. IGE FASTSCREEN S9 W1,6,9,10,11,12 02/21/1990
K900244 3M COMPANY 3M MULTI-ALLERGEN IGE FASTSCREEN(TM) S8 02/21/1990
K832360 ABBOTT LABORATORIES ABBOTT IGE EIA 10/14/1983
K895914 ABBOTT LABORATORIES ABBOTT IMX IGE 11/13/1989
K034057 ADIATEC SA LACRYTEST 03/09/2004
K885307 ALERCHEK, INC. FLIPSCREEN (TM) TOTAL E IMMUNOASSAY 03/08/1989
K822341 ALLERGENETICS ALLERGENETICS IGE-FAST TEST 11/10/1982
K833419 ALLERGENETICS LABELED 125I ANTI-IGE 02/03/1984
K834594 ALLERGENETICS TOTAL IGE FAST TEST 02/10/1984
K862368 ALLERTEC, INC. AMPLIFIED ELISA IGE KIT 07/03/1986
K831377 AMERICAN DIAGNOSTIC CORP. IGE RADIOIMMUNOASSAY KIT 06/02/1983
K823494 AXONICS, INC. TOTAL IGE-FAST TEST 01/14/1983
K024210 BECKMAN COULTER, INC. IMMAGE SYSTEMS TOTAL IMMUNOGLOBULIN E (IGE) REAGENT IMMAGE IGE CALIBRATOR 02/24/2003
K890530 BEHRING DIAGNOSTICS, INC. N LATEX IGE KIT (IMMUNOGLOBULIN E REAGENTS) 03/27/1989
K930984 BIO-RAD LABORATORIES, INC. ACCESS(R) TOTAL IGE ASSAY 06/09/1993
K912800 BIO-RAD LABORATORIES, INC. KALLESTEAD TOTAL IGE MICROPLATE KIT 07/25/1991
K801019 BIO-RIA 125I-IGE RADIOIMMUNOASSAY KIT 05/20/1980
K992528 BIOCHECK, INC. BIOCHECK IGE ELISA, MODEL BC-1035 09/21/1999
K910419 BIOCLONE AUSTRALIA PTY LTD. BIOCLONE'S ELEGANCE IGE ELISA KIT 06/21/1991
K050493 BIOKIT S.A. QUANTIA IGE 08/16/2005
K983185 BOEHRINGER MANNHEIM CORP. BOEHRINGER MANNHEIM TINA-QUANT IGE TEST 11/12/1998
K863822 BOEHRINGER MANNHEIM CORP. ENZYMUN-TEST(R) IGE 10/29/1986
K920372 CIBA CORNING DIAGNOSTICS CORP. ACS TOTAL IGE IMMUNOASSAY 04/08/1992
K934594 CIBA CORNING DIAGNOSTICS CORP. MAGIC LITE SQ SPECIFIC IGE IMMUNOASSAY SYSTEM 04/21/1994
K830357 CLINETICS CORP. RADIOIMMUNOASSAY IMMUNOGLOBULINS D.E 03/17/1983
K821092 CLINICAL ASSAYS, INC. GAMMADAB[125]EGE RADIOIMMUNOASSAY IT 06/22/1982
K853025 CLINICAL REFERENCE LABORATORY, INC. IMAGE-IGE 08/22/1985
K063425 DADE BEHRING, INC. DIMENSION VISTA IGE FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, PROTEIN 1 CONTROL MEDIUM, AND PROTEIN 1 CONTROL HIGH 02/15/2007
K991787 DADE BEHRING, INC. N LATEX IGE MONO REAGENT 07/07/1999
K892197 DIAGNOSTIC PRODUCTS CORP. ALATOP (TM) CATALOG # AKAL1 06/02/1989
K872913 DIAGNOSTIC PRODUCTS CORP. ALLEIA TOTAL IGE IRMA W/MONO. ANTI. RKIE 1,2,5 09/10/1987
K860033 DIAGNOSTIC PRODUCTS CORP. EIA MONOCLONAL TOTAL IGE KIT 04/07/1986
K895004 DIAGNOSTIC PRODUCTS CORP. MILENIA(TM) TOTAL IGE (MKIE1,5) 09/28/1989
K852878 DIAGNOSTIC PRODUCTS CORP. THE DPC MONOCLONAL EIA TOTAL IGE KIT 08/28/1985
K860032 DIAGNOSTIC PRODUCTS CORP. TOTAL IGE-IRMA RIA KIT 04/11/1986
K832345 DIAGNOSTIC REAGENT TECH. POLYSTYRENE MICROTITER WELL IMMUNOSOR 11/25/1983
K771238 G.D. SEARLE AND CO. RID PLATES & INTENSI. FOR HUMAN IGE ETC 07/15/1977
K843408 HYBRITECH, INC. ENCORE IGE REAGENT 10/01/1984
K802913 HYBRITECH, INC. TAN DEM* - IGE KIT 05/29/1981
K823507 HYBRITECH, INC. TANDEM-E -IGE IMMUNOEZYMETRIC ASSAY 12/28/1982
K863858 HYBRITECH, INC. TANDEM-M IMMUNOENZYMETRIC ASSAY FOR IGE-- 11/03/1986
K940183 HYCOR BIOMEDICAL, INC. HY-TEC TOTAL IGE ENZYME IMMUNOASSAY 05/17/1994
K780753 HYLAND THERAPEUTIC DIV., TRAVENOL LABORATORIES LAS-R HUMAN IGE TEST 06/06/1978
K032251 IMMUNETECH CORPORATION IMMUNETECH TOTAL IGE SYSTEM 12/19/2003
K862174 IMMUNO NUCLEAR CORP. TIMOTHY ALLERGEN DISC 08/06/1986
K874541 INCSTAR CORP. RRT TOTAL IGE TEST KIT 02/17/1988
K933180 INOVA DIAGNOSTICS, INC. QUANTA LITE MITOCHONDRIA M2 ELISA 08/05/1993
K923832 KABI PHARMACIA, INC. PHARMACIA CAP SYSTEM IGE FEIA -- MODIFICATION 11/25/1992
K831326 KALLESTAD LABORATORIES, INC. ALLERCOAT ALLERGEN DISCS 06/02/1983
K842125 KALLESTAD LABORATORIES, INC. ALLERCOAT ALLERGEN DISCS 06/07/1984
K823403 KALLESTAD LABORATORIES, INC. ALLERCOAT POSITIVE CONTROL SERUM 12/15/1982
K811545 KALLESTAD LABORATORIES, INC. KALLESTAD QUANTITOPE LOW LEVEL IGE REAG 06/24/1981
K852268 KALLESTAD LABORATORIES, INC. QUANTICLONE IGE RADIOIMMUNASSAY 07/10/1985
K822613 KALLESTAD LABORATORIES, INC. RAST ALLERCOAT ALLERGEN DISCS 10/22/1982
K781904 KALLESTAD LABORATORIES, INC. RIA KIT, QUANTITOPE IGE 02/08/1979
K822206 KALLESTAD LABORATORIES, INC. TOTAL IGE DISCS 08/16/1982
K042241 KAMIYA BIOMEDICAL CO. K-ASSAY TOTAL IGE, K-ASSAY IGE CALIBRATOR SET, MODELS KAI-092/KAI-093C 12/10/2004
K831208 LEECO DIAGNOSTICS, INC. IGE-QUANT DIAGNOSTIC TEST KIT 05/09/1983
K903195 LONDON DIAGNOSTICS, INC. LONDON DIAGNOSTICS LUMATAG (R) IGE CHEM. IMM ASSAY 08/02/1990
K830164 MAST IMMUNOSYSTEMS DENSITOMETRIC INHALENT PROFILE SLLER 03/01/1983
K841642 MAST IMMUNOSYSTEMS MAST LUMINESCENT ALLERGY SYS 06/07/1984
K833969 MAST IMMUNOSYSTEMS MAST TOTAL IGE 01/04/1984
K922047 MEDIX BIOTECH, INC. IGE ENZYME IMMUNOASSAY TEST KIT CAT.NO. KIF4064 08/05/1992
K874406 MEDIX BIOTECH, INC. IGE ENZYME IMMUNOASSAY TEST KIT NO. MB-1064 11/25/1987
K850786 NMS PHARMACEUTICALS, INC. TOTAL HIGE ENZYME IMMUNOASSAY 04/12/1985
K161899 PHADIA AB ImmunoCAP Total IgE Calibrator Strip/Total IgE Curve Control Strip, ImmunoCAP Total IgE Calibrators/Total IgE Curve Controls, ImmunoCAP Specific IgE Calibrator Strip/Specific IgE Curve Control Strip, ImmunoCAP Specific IgE Calibrators/Specific IgE Curve C 07/28/2016
K133404 PHADIA AB IMMUNOCAP TOTAL IGE: CONJUGATE, ANTI-IGE, CALIBRATORS, CURVE CONTROLS, CONTROL LMH 02/24/2014
K991945 PHARMACIA & UPJOHN CO. PHARMACIA CAP SYSTEM IGE FEIA, MODEL 10-9395-01 07/28/1999
K884545 PHARMACIA, INC. DELFIA (TM) HIGE KIT 11/10/1988
K823841 PHARMACIA, INC. PHADEBAS RAST ALLERGEN DISCS 01/12/1983
K841829 PHARMACIA, INC. PHADEBAS RAST PHADEZYM RAST ALLERGEN 06/07/1984
K813189 PHARMACIA, INC. PHADEBAS/PHADEZYM IGE REAGENTS 12/31/1981
K840538 PHARMACIA, INC. PHADEXACT SERUM, ALLERGEN SPECIFIC IGE 03/23/1984
K840476 PHARMACIA, INC. PHADEXACT SERUM, TOTAL IGE CONTROLS 05/21/1984
K810507 PHARMACIA, INC. PHADEZYM IGE PRIST TEST 03/20/1981
K823842 PHARMACIA, INC. PHADEZYM RAST ALLERGEN DISCS 01/12/1983
K893951 PHARMACIA, INC. PHARMACIA CAP SYSTEM IGE RIA AND FEIA 07/14/1989
K882626 PHARMACIA, INC. PHARMACIA IGE EIA ULTRA 08/04/1988
K841824 PHARMACIA, INC. PHARMACIA IGE RIA 06/07/1984
K851156 PHARMACIA, INC. PHARMACIA IGE RIA MODIFIED 04/25/1985
K882625 PHARMACIA, INC. PHARMACIA IGE RIA ULTRA 08/08/1988
K881892 PHARMACIA, INC. PHARMACIA IGE RIACT 06/10/1988
K911631 PHARMACIA, INC. PHARMACIA SPECIFIC IGE CONTROL 04/24/1991
K964152 PHARMACIA, INC. UNICAP TOTAL IGE ASSAY/PHARMACIA TOTAL IGE CONTROLS LMH 04/23/1997
K895294 PROGENE CORP. PROGENE IGE BEAD EIA 09/21/1989
K910082 QUIDEL CORP. POSITIVE CONTROL PAD FOR TOTAL IGE TEST DIPSTICK 03/12/1991
K903738 QUIDEL CORP. QUIDEL ALLERGEN SCREEN POSITIVE CONTROL 10/15/1990
K861171 QUIDEL CORP. QUIDEL ALLERGY SCREEN 04/25/1986
K010855 RANDOX LABORATORIES, LTD. RANDOX IGE 05/15/2001
K930890 ROCHE DIAGNOSTIC SYSTEMS, INC. COBAS(R) CORE IGE TOTAL EIA 08/05/1993
K843369 SCIENTIFIC RESEARCH AGGLUTINATION TEST FOR TOTAL IGE 11/14/1984
K843710 SCIENTIFIC RESEARCH ELISA FOR TOTAL IGE 10/22/1984
K872968 SPECIALTY MEDICAL INDUSTRIES, INC. ULTRASCAN IGE ASSAY KIT 08/28/1987
K840674 TERUMO MEDICAL CORP. SENSIBEAD EIA IGE KIT 04/04/1984
K002560 THE BINDING SITE, LTD. SHEEP ANTI-HUMAN IGE IMMUNOFIXATION GRADE KIT 10/26/2000
K972697 TOSOH MEDICS, INC. AIA-PACK IGE II ASSAY 10/03/1997
K991316 TOUCH SCIENTIFIC, INC. TOUCH TEAR IGE MICROASSAY KIT 08/09/1999
K864142 UNITED BIOTECH, INC. UBI MAGIWEL(TM) IGE QUANTITATIVE AND QUALITATIVE 12/03/1986
K832218 VENTREX LABORATORIES, INC. ALLERGEN CONTROL INHALENT 09/20/1983
K830817 VENTREX LABORATORIES, INC. NEW ALLERGEN DISCS FOR USE IN VAST VENT 04/27/1983
K821615 VENTREX LABORATORIES, INC. VAST VENTREX PD IGE RIA TEST SET 06/10/1982
K841651 VENTREX LABORATORIES, INC. VAST VENTREX RAST ALL 06/01/1984
K822442 VENTREX LABORATORIES, INC. VAST VENTREX RAST ALLERGEN DISCS 09/02/1982
K811559 VENTREX LABORATORIES, INC. VENTRE/SEP IGE RIA TEST SET 07/10/1981
K820978 VENTREX LABORATORIES, INC. VENTRE/SPEC ALLERGEN CONTROL-INHALANT 06/11/1982
K820977 VENTREX LABORATORIES, INC. VENTRE/SPEC ALLERGEN CONTROL-MOLDS/FOOD 06/11/1982
K820897 VENTREX LABORATORIES, INC. VENTRE/SPEC IGE CONTROLS 05/05/1982
K831485 VENTREX LABORATORIES, INC. VENTRE/ZYME IGE KIT 06/02/1983
K820896 VENTREX LABORATORIES, INC. VENTREX 125I ANTI-IGE ALLERGY ISOTOPE 04/21/1982
K905612 VENTREX LABORATORIES, INC. VENTREX COATED TUBE IGE RADIOIMMUNOASSAY 02/21/1991


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