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

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
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


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