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 |
| 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 |
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