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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