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

FDA 510(k) Number Applicant Device Name Decision Date
K983221 ABBOTT LABORATORIES IGG 11/04/1998
K852589 ABBOTT LABORATORIES TDX IMMUNOGLOBULIN G DIAGNOSTIC KIT 07/15/1985
K872800 ABBOTT LABORATORIES TDX IMMUNOGLOBULIN G DIAGNOSTIC KIT 08/12/1987
K850583 APPLICATIONS LAB SPQ TEST SYSTEM FOR IMMUNOGLOBULIN G 03/01/1985
K890416 ATLANTIC ANTIBODIES SPQ(TM) ANTIBODY REAGENT SET II FOR IGG 02/22/1989
K842329 BARTELS IMMUNODIAGNOSTIC SUPPLIES, INC. AMER. HISTO-ID SYS PRIMARY IGG S7920-11 08/02/1984
K951635 BECKMAN INSTRUMENTS, INC. BECKMAN IMMUNOGLOBULIN G (IGG) REAGENT, URINE APPLICATION, URINE PROTEIN CALIBRATOR, CONTROL 05/15/1995
K963974 BECKMAN INSTRUMENTS, INC. IMAGE-IMMUNOCHEMISTRY SYSTEM URINE IMMUNOGLOBULIN 03/06/1997
K963868 BECKMAN INSTRUMENTS, INC. IMMAGE IMMUNOCHEMISTRY SYSTEM IMMUNOGLOBULIN G (IGG), A (IGA) AND M (IGM) 02/10/1997
K965108 BECKMAN INSTRUMENTS, INC. SYNCHRON LX SYSTEMS IMMUNOGLOBULIN G/A/M REAGENT 03/06/1997
K943997 BEHRING DIAGNOSTICS, INC. BEHRING NEPHELOMETER II 10/03/1994
K933314 BIO-RAD RADIAS FERRITIN ENZYME IMMUNOASSAY 09/08/1993
K875356 BIRMINGHAM IMMUNOGLOBULIN G & G SUBCLASSES 02/10/1988
K862764 BOEHRINGER MANNHEIM CORP. TINA-QUANT(R) IGG 09/03/1986
K800119 CALBIOCHEM-BEHRING CORP. IMMUNOGLOBULIN G REAGENT SYSTEM 02/05/1980
K851541 COULTER ELECTRONICS, INC. DART IMMUNOGLOBULINS REAGENT SYSTEM 07/15/1985
K893419 COULTER IMMUNOLOGY COULTER CLONE GAM-FITC POLY ANTI (IGG & IGM) 08/03/1989
K861059 DAKO CORP. DAKO ITA SYSTEM 08/25/1986
K812484 DAKO CORP. DAKO PAP KIT K505 02/10/1982
K812495 DAKO CORP. IMMUNOGL. FRCT. OF RABBIT ANTISER.-ALPHA 09/23/1981
K812489 DAKO CORP. IMMUNOGL. FRCT. OF RABBIT ANTISER.-IGG 09/23/1981
K791285 DIAGNOSTICA, INC. ANTI-HUMAN GLOBULINS 10/17/1979
K791281 DIAGNOSTICA, INC. ANTI-HUMAN IGG SERUM 11/27/1979
K800398 DIAGNOSTICA, INC. PARACONTROL ABNORMAL IMMUNOGLOBULIN CONT 03/12/1980
K812664 E.I. DUPONT DE NEMOURS & CO., INC. "ACA" IMMUNOGLOBULIN G ANALYTICAL TEST 10/02/1981
K812630 E.I. DUPONT DE NEMOURS & CO., INC. ACA IMMUNOGLOBULIN G CALIBRATOR 09/29/1981
K800451 ELECTRO-NUCLEONICS LABORATORIES, INC. GEMENI IGG ASSAY 04/24/1980
K832264 GELCO DIAGNOSTICS, INC. FITC GOAT ANTI-HUMAN IGG Y CHAIN 10/28/1983
K832258 GELCO DIAGNOSTICS, INC. GOAT ANTI-HUMAN IGG Y CHAIN SPECIFIC 10/31/1983
K772077 GELMAN INSTRUMENT CO. RADIAL IMMUNODIFFUSION KIT-IMMUNOGLOB.G 02/03/1978
K853465 GILFORD GILFORD IMMUNOGLOBULIN G REAGENT 09/16/1985
K875254 GULL LABORATORIES, INC. GULLSORB IGG INACTIVATION REAGENT 02/17/1988
K871352 HELENA LABORATORIES PENTAVALENT ANTISERUM TO HUMAN IMMUNOGLOBULINS 04/22/1987
K010617 HELENA LABORATORIES SPIFE IFE CALIBRATOR AND CONTROL KIT 03/15/2001
K830594 HELENA LABORATORIES TITAN IMMUNO-FIX 03/24/1983
K811126 ICL SCIENTIFIC AIM SYSTEM (FOR IGG) 05/08/1981
K791824 ICL SCIENTIFIC ANTISERUM TO HUMAN IMMUNOGLOBULINS 10/17/1979
K810056 ICL SCIENTIFIC IMMUNOLOGY CONTROL SERUM 02/09/1981
K800897 ICL SCIENTIFIC RID SYSTEM-QUAD MULTITEST IGG, IGA,ETC. 05/08/1980
K882369 ICN IMMUNOBIOLOGICALS ACCRAASSAY RID KITS 07/12/1988
K962202 INSTRUMENTATION LABORATORY CO. QUANTEX IGG 09/26/1996
K761224 INTL. DIAGNOSTIC TECHNOLOGY ULTRA LOW LEVEL IMMUNOGLOBULIN G 04/07/1977
K801281 J.T. BAKER CHEMICAL CO. J.T. BAKER IMMUNOGLOBULIN G NEPHELOMETRI 06/20/1980
K911610 JANSSEN RESEARCH FOUNDATION ELISA COMBI-KIT HUMAN IGG SUBCLASSES 06/12/1991
K882083 KALLESTAD DIAG, A DIV. OF ERBAMONT, INC. QM300 IGG ANTIBODY PACK 07/08/1988
K871340 KALLESTAD DIAG, A DIV. OF ERBAMONT, INC. QM300 IGG ANTIBODY PACK 04/22/1987
K770961 KALLESTAD LABORATORIES, INC. GOAT ANTISERUM IGG NEPHELOMETRIC 06/24/1977
K772252 KALLESTAD LABORATORIES, INC. IMMUNOGLOBULIN G NEPHEL. ASSAY 12/22/1977
K993281 KAMIYA BIOMEDICAL CO. K-ASSAY IGG 11/09/1999
K790704 KENT LABORATORIES, INC. ANTISERUM TO HUMAN IGG 04/12/1979
K790702 KENT LABORATORIES, INC. ANTISERUM, HUMAN, IGG H & L CHAIN 09/04/1979
K770484 KENT LABORATORIES, INC. FLUOR. CONJUGATED ANTISERUM 03/21/1977
K770668 KENT LABORATORIES, INC. FLUORESCEIN CONJUGATED ANTISERUM 04/28/1977
K770669 KENT LABORATORIES, INC. RHODAMINE-CONJUGATED ANTISERUM 04/28/1977
K821018 MICROBIOLOGICAL RESEARCH CORP. ANTIHUMAN IGG GLOBULIN FITC LABELED 04/29/1982
K841816 MILES LABORATORIES, INC. OPTIMATE IGG TEST 06/22/1984
K934324 ORGANON TEKNIKA CORP. OT IGG SORBENT 04/21/1994
K770597 ORGANON, INC. DASP TM ANTI-RABBIT 04/28/1977
K760145 OXFORD LABORATORIES, INC. SERUM, IGG GOAT ANTI-HUMAN ACID 07/19/1976
K810694 PHARMACIA, INC. PHADEBAS IGG RAST TEST 07/23/1981
K802257 PROTOS LABORATORIES GOAT ANTI-HUMAN IGG GAMMA CHAIN SPECIFIC 10/31/1980
K955798 RANDOX LABORATORIES, LTD. IGG IMMUNOTURBIDIMETRIC & CALIBRATOR 04/05/1996
K040434 ROCHE DIAGNOSTICS CORP. ROCHE DIAGNOSTICS TINA-QUANT IGG GEN.2 03/10/2004
K050113 ROCHE DIAGNOSTICS CORP. TINA-QUANT IGG GEN.2 02/08/2005
K812453 SCRIPPS-MILES, INC. SCRIPPSYSTEM IMMUNOGLOBIN RID KIT 09/23/1981
K812328 SCRIPPS-MILES, INC. SCRIPPSYSTEM NEPHELOMETRIC ANTISERA KIT 09/08/1981
K791403 SHERWOOD MEDICAL CO. LANCER L-INA ANTI-IGG 10/17/1979
K900943 TECHNICON INSTRUMENTS CORP. MODIFIED TECHNICON DPA-1(TM) SYSTEM 04/26/1990
K833402 TECHNICON INSTRUMENTS CORP. TECH. RA-1000SYS-ANALYTES IMMUNOGLOBULIN 01/24/1984
K873870 UNIPATH LTD. IMMUNOGLOBULINS G 10/13/1987
K921575 VIROTECH DIAGNOSTIKA IGG SUCLASS EIA 05/28/1992
K891385 VITEK SYSTEMS, INC. VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM (VIDAS) 04/18/1989
K880784 WAKO CHEMICALS, USA, INC. WAKO(TM) IGG-HA DIRECT 06/06/1988
K993928 WAKO CHEMICALS, USA, INC. WAKO-IGG II-HA, IMMUNOGLOBULIN CALIBRATOR SET, IMMUNOLOBULIN STANDARD 01/18/2000
K831101 WORTHINGTON DIAGNOSTIC SYSTEMS TIA-IGG REAGENT & CALIBRATOR SETS 04/27/1983
K924197 ZEUS SCIENTIFIC, INC. ZORBA(TM) IGG REMOVAL REAGENT 12/15/1992


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