Panels › Immunology › Product code CZP · Class 2
Iga, Antigen, Antiserum, Control
Regulation 866.5510
0510(k)s in 12 months (54 all time)
0recalls in 12 months (3 all time)
3recalls that name a 510(k)
Top companies in CZP
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 26, 2020 | K193525 | Yumizen C1200 Immunoglobulin A, Yumizen C1200 Immunoglobulin G, Yumizen C1200 Immunoglobulin M HORIBA ABX SAS, FR | CZP |
| Feb 13, 2006 | K060130 | IMMAGE SYSTEMS LOW CONCENTRATION IMMUNOGLOBULIN A REAGENT Beckman Coulter, Inc. | CZP |
| Mar 10, 2004 | K040435 | ROCHE DIAGNOSTICS TINA-QUANT IGA GEN.2 Roche Diagnostics Corp. | CZP |
| Feb 13, 2003 | K024038 | N LATEX IGA Dade Behring, Inc. | CZP |
| Jan 14, 2000 | K993927 | WAKO IGA II-HA, IMMUNOGLOBULIN CALIBRATOR SET, IMMUNOGLOBULIN STANDRAD Wako Chemicals USA, Inc. | CZP |
| Nov 4, 1998 | K983359 | IGA Abbott Laboratories | CZP |
| Sep 25, 1996 | K962200 | QUANTEX IGA Instrumentation Laboratory CO | CZP |
| Apr 5, 1996 | K955794 | IGA IMMUNOTURBIDIMETRIC & CALIBRATOR Randox Laboratories, Ltd., IE | CZP |
| Feb 9, 1996 | K955907 | BOEHRINGER MANNHEIM IGA ASSAY Boehringer Mannheim Corp. | CZP |
| Jun 20, 1995 | K952309 | N LATEX IGA Behring Diagnostics, Inc. | CZP |
| Jul 16, 1993 | K931806 | IGA SUBCLASS RID KIT FOR DIAGNOSTIC USE The Binding Site, Ltd. | CZP |
| Jun 16, 1992 | K920014 | IL TEST IMMUNOGLOBULIN A Instrumentation Laboratory CO | CZP |
| Feb 27, 1990 | K900422 | TITAN GEL IMMUNOFIX KIT, CAT. NO. 3046 Helena Laboratories | CZP |
| Aug 2, 1989 | K894418 | RAICHEM(TM) SPIA(TM) IGA REAGENTS Reagents Applications, Inc. | CZP |
| Feb 15, 1989 | K890560 | SPQ(TM) ANTIBODY REAGENT SET II FOR IGA Atlantic Antibodies | CZP |
| Oct 19, 1988 | K884040 | IMMUNOCHEMICAL DETERMINATION OF IMMUNOGLOBULIN A Orion Diagnostica, Inc., FI | CZP |
| Sep 22, 1988 | K883492 | TECHNICON DPA-1 IMMUNOGLOBULIN A Technicon Instruments Corp. | CZP |
| Mar 29, 1988 | K880803 | WAKO(TM) IGA-HA DIRECT Wako Chemicals USA, Inc. | CZP |
| Oct 13, 1987 | K873869 | IMMUNOGLOBULINS A Unipath , Ltd., GB | CZP |
| Jun 12, 1987 | K871940 | QM300 IGA, ANTIGEN, ANTISERUM, CONTROL Kallestad Diag, A Div. of Erbamont, Inc. | CZP |
| Sep 17, 1986 | K863352 | PRECIMAT (R) IGA, G, M Boehringer Mannheim Corp. | CZP |
| Sep 4, 1986 | K862763 | TINA-QUANT(R) IGA Boehringer Mannheim Corp. | CZP |
| Aug 27, 1986 | K855046 | TDX IMMUNOGLOBULIN A DIAGNOSTIC KIT Abbott Laboratories | CZP |
| Aug 19, 1986 | K862183 | DAKO ITA, IMMUNOGLOBULIN A (IGA) Dako Corp. | CZP |
| Apr 25, 1986 | K861167 | IMMUNOGLOBULINS A,G,M,D,E IMMUNOLOGICAL TEST Atlantic Antibodies | CZP |
| Feb 26, 1986 | K855009 | QUANTIMETRIC PLUS IGA REAGENT KIT Kallestad Laboratories, Inc. | CZP |
| Sep 16, 1985 | K853467 | GILFORD IMMUNOGLOBULIN A REAGENT Gilford | CZP |
| Jun 11, 1985 | K851284 | RADIAL IMMUNO-DIFFUSION PLATES IGA, IGD, IGG & IGM Cooper Biomedical, Inc. | CZP |
| Mar 1, 1985 | K850582 | SPQ TEST SYSTEM FOR IMMUNOGLOBULIN A Applications Lab | CZP |
| Oct 5, 1984 | K843614 | CORNING IMMUNOFIXATION SYS Corning Medical & Scientific | CZP |
| Aug 28, 1984 | K842468 | TISSUE-TEK IMMUNOHISTOLOGY KIT IGA/IGG Miles Laboratories, Inc. | CZP |
| Aug 2, 1984 | K842330 | AMER. HISTO-ID SYS PRIMARY IGA 2720-21 Bartels Immunodiagnostic Supplies, Inc. | CZP |
| Oct 31, 1983 | K832263 | FITC GOAT ANTI-HUMAN IGA A CHAIN Gelco Diagnostics, Inc. | CZP |
| Apr 27, 1983 | K831102 | TIA-IGA REAGENT & CALIBRATOR SETS Worthington Diagnostic Systems | CZP |
| Dec 30, 1982 | K823567 | IMMUNOGLOBULIN ASSAYS-IGG, IGA, IGM Syva Co. | CZP |
| Dec 30, 1982 | K823566 | IMMUNOGLOBULIN CONTROL Syva Co. | CZP |
| Aug 3, 1982 | K822026 | IMMUNO DIAGNOSTICS ASSAY Helena Laboratories | CZP |
| Sep 29, 1981 | K812633 | ACA IMMUNOGLOBULIN A/M CALIBRATORS E.I. Dupont DE Nemours & Co., Inc. | CZP |
| Sep 29, 1981 | K812631 | ACA IMMUNOGLOBIN A TEST PACK E.I. Dupont DE Nemours & Co., Inc. | CZP |
| Sep 23, 1981 | K812488 | IMMUNOGL. FRCT. OF RABBIT ANTISER.-IGA Dako Corp. | CZP |
| Sep 1, 1981 | K812253 | GELMAN IG-FIX KIT Gelman Sciences, Inc. | CZP |
| May 8, 1981 | K811125 | AIM SYSTEM (FOR IGA) Icl Scientific | CZP |
| Jan 26, 1981 | K803274 | AUTOMATED IMMUNOPRECIPITIN METHOD/IGA Icl Scientific | CZP |
| Jun 30, 1980 | K801283 | J.T. BAKER IMMUNO. A NEPHELOMETRIC ASSAY J.T. Baker Chemical Co. | CZP |
| Mar 12, 1980 | K800449 | GEMENI IGA ASSAY Electro-Nucleonics Laboratories, Inc. | CZP |
| Feb 19, 1980 | K800211 | IMMUNOGLOBULIN A REAGENT SYSTEM Calbiochem-Behring Corp. | CZP |
| Oct 17, 1979 | K791401 | LANCER L-INA ANTI-IGA Sherwood Medical Co. | CZP |
| Apr 12, 1979 | K790703 | ANTISERUM, HUMAN, IGA Kent Laboratories, Inc. | CZP |
| Apr 3, 1979 | K790479 | A-GENT IMMUNOGLOBULINE TEST SYSTEM Abbott Laboratories | CZP |
| Feb 3, 1978 | K772076 | RADIAL IMMUNODIFFUSION KIT-IMMUNOGLOB. Gelman Instrument Co. | CZP |
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