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 |
K871340 |
KALLESTAD DIAG, A DIV. OF ERBAMONT, INC. |
QM300 IGG ANTIBODY PACK |
04/22/1987 |
K882083 |
KALLESTAD DIAG, A DIV. OF ERBAMONT, INC. |
QM300 IGG ANTIBODY PACK |
07/08/1988 |
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 |