FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K790479 |
ABBOTT LABORATORIES |
A-GENT IMMUNOGLOBULINE TEST SYSTEM |
04/03/1979 |
K983359 |
ABBOTT LABORATORIES |
IGA |
11/04/1998 |
K855046 |
ABBOTT LABORATORIES |
TDX IMMUNOGLOBULIN A DIAGNOSTIC KIT |
08/27/1986 |
K850582 |
APPLICATIONS LAB |
SPQ TEST SYSTEM FOR IMMUNOGLOBULIN A |
03/01/1985 |
K861167 |
ATLANTIC ANTIBODIES |
IMMUNOGLOBULINS A,G,M,D,E IMMUNOLOGICAL TEST |
04/25/1986 |
K890560 |
ATLANTIC ANTIBODIES |
SPQ(TM) ANTIBODY REAGENT SET II FOR IGA |
02/15/1989 |
K842330 |
BARTELS IMMUNODIAGNOSTIC SUPPLIES, INC. |
AMER. HISTO-ID SYS PRIMARY IGA 2720-21 |
08/02/1984 |
K060130 |
BECKMAN COULTER, INC. |
IMMAGE SYSTEMS LOW CONCENTRATION IMMUNOGLOBULIN A REAGENT |
02/13/2006 |
K771603 |
BECKMAN INSTRUMENTS, INC. |
IMMOCHEMISTRY SYSTEM |
09/15/1977 |
K952309 |
BEHRING DIAGNOSTICS, INC. |
N LATEX IGA |
06/20/1995 |
K955907 |
BOEHRINGER MANNHEIM CORP. |
BOEHRINGER MANNHEIM IGA ASSAY |
02/09/1996 |
K863352 |
BOEHRINGER MANNHEIM CORP. |
PRECIMAT (R) IGA, G, M |
09/17/1986 |
K862763 |
BOEHRINGER MANNHEIM CORP. |
TINA-QUANT(R) IGA |
09/04/1986 |
K800211 |
CALBIOCHEM-BEHRING CORP. |
IMMUNOGLOBULIN A REAGENT SYSTEM |
02/19/1980 |
K851284 |
COOPER BIOMEDICAL, INC. |
RADIAL IMMUNO-DIFFUSION PLATES IGA, IGD, IGG & IGM |
06/11/1985 |
K843614 |
CORNING MEDICAL & SCIENTIFIC |
CORNING IMMUNOFIXATION SYS |
10/05/1984 |
K024038 |
DADE BEHRING, INC. |
N LATEX IGA |
02/13/2003 |
K862183 |
DAKO CORP. |
DAKO ITA, IMMUNOGLOBULIN A (IGA) |
08/19/1986 |
K812488 |
DAKO CORP. |
IMMUNOGL. FRCT. OF RABBIT ANTISER.-IGA |
09/23/1981 |
K812631 |
E.I. DUPONT DE NEMOURS & CO., INC. |
ACA IMMUNOGLOBIN A TEST PACK |
09/29/1981 |
K812633 |
E.I. DUPONT DE NEMOURS & CO., INC. |
ACA IMMUNOGLOBULIN A/M CALIBRATORS |
09/29/1981 |
K800449 |
ELECTRO-NUCLEONICS LABORATORIES, INC. |
GEMENI IGA ASSAY |
03/12/1980 |
K832263 |
GELCO DIAGNOSTICS, INC. |
FITC GOAT ANTI-HUMAN IGA A CHAIN |
10/31/1983 |
K772076 |
GELMAN INSTRUMENT CO. |
RADIAL IMMUNODIFFUSION KIT-IMMUNOGLOB. |
02/03/1978 |
K812253 |
GELMAN SCIENCES, INC. |
GELMAN IG-FIX KIT |
09/01/1981 |
K853467 |
GILFORD |
GILFORD IMMUNOGLOBULIN A REAGENT |
09/16/1985 |
K822026 |
HELENA LABORATORIES |
IMMUNO DIAGNOSTICS ASSAY |
08/03/1982 |
K900422 |
HELENA LABORATORIES |
TITAN GEL IMMUNOFIX KIT, CAT. NO. 3046 |
02/27/1990 |
K193525 |
Horiba ABX SAS |
Yumizen C1200 Immunoglobulin A, Yumizen C1200 Immunoglobulin G, Yumizen C1200 Immunoglobulin M |
06/26/2020 |
K811125 |
ICL SCIENTIFIC |
AIM SYSTEM (FOR IGA) |
05/08/1981 |
K803274 |
ICL SCIENTIFIC |
AUTOMATED IMMUNOPRECIPITIN METHOD/IGA |
01/26/1981 |
K920014 |
INSTRUMENTATION LABORATORY CO. |
IL TEST IMMUNOGLOBULIN A |
06/16/1992 |
K962200 |
INSTRUMENTATION LABORATORY CO. |
QUANTEX IGA |
09/25/1996 |
K801283 |
J.T. BAKER CHEMICAL CO. |
J.T. BAKER IMMUNO. A NEPHELOMETRIC ASSAY |
06/30/1980 |
K871940 |
KALLESTAD DIAG, A DIV. OF ERBAMONT, INC. |
QM300 IGA, ANTIGEN, ANTISERUM, CONTROL |
06/12/1987 |
K770962 |
KALLESTAD LABORATORIES, INC. |
GOAT ANTISERUM IGA NEPHELOMETRIC |
06/24/1977 |
K772251 |
KALLESTAD LABORATORIES, INC. |
IMMUNOGLOBULIN A NEPHEL. ASSAY |
12/22/1977 |
K855009 |
KALLESTAD LABORATORIES, INC. |
QUANTIMETRIC PLUS IGA REAGENT KIT |
02/26/1986 |
K790703 |
KENT LABORATORIES, INC. |
ANTISERUM, HUMAN, IGA |
04/12/1979 |
K842468 |
MILES LABORATORIES, INC. |
TISSUE-TEK IMMUNOHISTOLOGY KIT IGA/IGG |
08/28/1984 |
K884040 |
ORION DIAGNOSTICA, INC. |
IMMUNOCHEMICAL DETERMINATION OF IMMUNOGLOBULIN A |
10/19/1988 |
K760146 |
OXFORD LABORATORIES, INC. |
SERUM, IGA GOAT ANTI-HUMAN ACID |
07/20/1976 |
K955794 |
RANDOX LABORATORIES, LTD. |
IGA IMMUNOTURBIDIMETRIC & CALIBRATOR |
04/05/1996 |
K894418 |
REAGENTS APPLICATIONS, INC. |
RAICHEM(TM) SPIA(TM) IGA REAGENTS |
08/02/1989 |
K040435 |
ROCHE DIAGNOSTICS CORP. |
ROCHE DIAGNOSTICS TINA-QUANT IGA GEN.2 |
03/10/2004 |
K791401 |
SHERWOOD MEDICAL CO. |
LANCER L-INA ANTI-IGA |
10/17/1979 |
K823567 |
SYVA CO. |
IMMUNOGLOBULIN ASSAYS-IGG, IGA, IGM |
12/30/1982 |
K823566 |
SYVA CO. |
IMMUNOGLOBULIN CONTROL |
12/30/1982 |
K883492 |
TECHNICON INSTRUMENTS CORP. |
TECHNICON DPA-1 IMMUNOGLOBULIN A |
09/22/1988 |
K931806 |
THE BINDING SITE, LTD. |
IGA SUBCLASS RID KIT FOR DIAGNOSTIC USE |
07/16/1993 |
K873869 |
UNIPATH LTD. |
IMMUNOGLOBULINS A |
10/13/1987 |
K993927 |
WAKO CHEMICALS, USA, INC. |
WAKO IGA II-HA, IMMUNOGLOBULIN CALIBRATOR SET, IMMUNOGLOBULIN STANDRAD |
01/14/2000 |
K880803 |
WAKO CHEMICALS, USA, INC. |
WAKO(TM) IGA-HA DIRECT |
03/29/1988 |
K831102 |
WORTHINGTON DIAGNOSTIC SYSTEMS |
TIA-IGA REAGENT & CALIBRATOR SETS |
04/27/1983 |