FDA Product Code
FDA Product Code CZP — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Immunology
- 21 CFR Citation
- 866.5510
510(k) Clearances — 54 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K193525 | Yumizen C1200 Immunoglobulin A, Yumizen C1200 Immunoglobulin G, Yumizen C1200 Immunoglobulin M | HORIBA ABX SAS | 2020-06-26 | Traditional | PDF ↗ |
| K060130 | IMMAGE SYSTEMS LOW CONCENTRATION IMMUNOGLOBULIN A REAGENT | Beckman Coulter, Inc. | 2006-02-13 | Special | PDF ↗ |
| K040435 | ROCHE DIAGNOSTICS TINA-QUANT IGA GEN.2 | Roche Diagnostics Corp. | 2004-03-10 | Special | PDF ↗ |
| K024038 | N LATEX IGA | Dade Behring, Inc. | 2003-02-13 | Traditional | PDF ↗ |
| K993927 | WAKO IGA II-HA, IMMUNOGLOBULIN CALIBRATOR SET, IMMUNOGLOBULIN STANDRAD | Wako Chemicals USA, Inc. | 2000-01-14 | Traditional | PDF ↗ |
| K983359 | IGA | Abbott Laboratories | 1998-11-04 | Traditional | PDF ↗ |
| K962200 | QUANTEX IGA | Instrumentation Laboratory CO | 1996-09-25 | Traditional | PDF ↗ |
| K955794 | IGA IMMUNOTURBIDIMETRIC & CALIBRATOR | Randox Laboratories, Ltd. | 1996-04-05 | Traditional | PDF ↗ |
| K955907 | BOEHRINGER MANNHEIM IGA ASSAY | Boehringer Mannheim Corp. | 1996-02-09 | Traditional | PDF ↗ |
| K952309 | N LATEX IGA | Behring Diagnostics, Inc. | 1995-06-20 | Traditional | PDF ↗ |
| K931806 | IGA SUBCLASS RID KIT FOR DIAGNOSTIC USE | The Binding Site, Ltd. | 1993-07-16 | Traditional | PDF ↗ |
| K920014 | IL TEST IMMUNOGLOBULIN A | Instrumentation Laboratory CO | 1992-06-16 | Traditional | PDF ↗ |
| K900422 | TITAN GEL IMMUNOFIX KIT, CAT. NO. 3046 | Helena Laboratories | 1990-02-27 | Traditional | PDF ↗ |
| K894418 | RAICHEM(TM) SPIA(TM) IGA REAGENTS | Reagents Applications, Inc. | 1989-08-02 | Traditional | PDF ↗ |
| K890560 | SPQ(TM) ANTIBODY REAGENT SET II FOR IGA | Atlantic Antibodies | 1989-02-15 | Traditional | PDF ↗ |
| K884040 | IMMUNOCHEMICAL DETERMINATION OF IMMUNOGLOBULIN A | Orion Diagnostica, Inc. | 1988-10-19 | Traditional | PDF ↗ |
| K883492 | TECHNICON DPA-1 IMMUNOGLOBULIN A | Technicon Instruments Corp. | 1988-09-22 | Traditional | PDF ↗ |
| K880803 | WAKO(TM) IGA-HA DIRECT | Wako Chemicals USA, Inc. | 1988-03-29 | Traditional | PDF ↗ |
| K873869 | IMMUNOGLOBULINS A | Unipath , Ltd. | 1987-10-13 | Traditional | PDF ↗ |
| K871940 | QM300 IGA, ANTIGEN, ANTISERUM, CONTROL | Kallestad Diag, A Div. of Erbamont, Inc. | 1987-06-12 | Traditional | PDF ↗ |
| K863352 | PRECIMAT (R) IGA, G, M | Boehringer Mannheim Corp. | 1986-09-17 | Traditional | PDF ↗ |
| K862763 | TINA-QUANT(R) IGA | Boehringer Mannheim Corp. | 1986-09-04 | Traditional | PDF ↗ |
| K855046 | TDX IMMUNOGLOBULIN A DIAGNOSTIC KIT | Abbott Laboratories | 1986-08-27 | Traditional | PDF ↗ |
| K862183 | DAKO ITA, IMMUNOGLOBULIN A (IGA) | Dako Corp. | 1986-08-19 | Traditional | PDF ↗ |
| K861167 | IMMUNOGLOBULINS A,G,M,D,E IMMUNOLOGICAL TEST | Atlantic Antibodies | 1986-04-25 | Traditional | PDF ↗ |
| K855009 | QUANTIMETRIC PLUS IGA REAGENT KIT | Kallestad Laboratories, Inc. | 1986-02-26 | Traditional | PDF ↗ |
| K853467 | GILFORD IMMUNOGLOBULIN A REAGENT | Gilford | 1985-09-16 | Traditional | PDF ↗ |
| K851284 | RADIAL IMMUNO-DIFFUSION PLATES IGA, IGD, IGG & IGM | Cooper Biomedical, Inc. | 1985-06-11 | Traditional | PDF ↗ |
| K850582 | SPQ TEST SYSTEM FOR IMMUNOGLOBULIN A | Applications Lab | 1985-03-01 | Traditional | PDF ↗ |
| K843614 | CORNING IMMUNOFIXATION SYS | Corning Medical & Scientific | 1984-10-05 | Traditional | PDF ↗ |
| K842468 | TISSUE-TEK IMMUNOHISTOLOGY KIT IGA/IGG | Miles Laboratories, Inc. | 1984-08-28 | Traditional | PDF ↗ |
| K842330 | AMER. HISTO-ID SYS PRIMARY IGA 2720-21 | Bartels Immunodiagnostic Supplies, Inc. | 1984-08-02 | Traditional | PDF ↗ |
| K832263 | FITC GOAT ANTI-HUMAN IGA A CHAIN | Gelco Diagnostics, Inc. | 1983-10-31 | Traditional | PDF ↗ |
| K831102 | TIA-IGA REAGENT & CALIBRATOR SETS | Worthington Diagnostic Systems | 1983-04-27 | Traditional | PDF ↗ |
| K823567 | IMMUNOGLOBULIN ASSAYS-IGG, IGA, IGM | Syva Co. | 1982-12-30 | Traditional | PDF ↗ |
| K823566 | IMMUNOGLOBULIN CONTROL | Syva Co. | 1982-12-30 | Traditional | PDF ↗ |
| K822026 | IMMUNO DIAGNOSTICS ASSAY | Helena Laboratories | 1982-08-03 | Traditional | PDF ↗ |
| K812633 | ACA IMMUNOGLOBULIN A/M CALIBRATORS | E.I. Dupont DE Nemours & Co., Inc. | 1981-09-29 | Traditional | PDF ↗ |
| K812631 | ACA IMMUNOGLOBIN A TEST PACK | E.I. Dupont DE Nemours & Co., Inc. | 1981-09-29 | Traditional | PDF ↗ |
| K812488 | IMMUNOGL. FRCT. OF RABBIT ANTISER.-IGA | Dako Corp. | 1981-09-23 | Traditional | PDF ↗ |
| K812253 | GELMAN IG-FIX KIT | Gelman Sciences, Inc. | 1981-09-01 | Traditional | PDF ↗ |
| K811125 | AIM SYSTEM (FOR IGA) | Icl Scientific | 1981-05-08 | Traditional | PDF ↗ |
| K803274 | AUTOMATED IMMUNOPRECIPITIN METHOD/IGA | Icl Scientific | 1981-01-26 | Traditional | PDF ↗ |
| K801283 | J.T. BAKER IMMUNO. A NEPHELOMETRIC ASSAY | J.T. Baker Chemical Co. | 1980-06-30 | Traditional | PDF ↗ |
| K800449 | GEMENI IGA ASSAY | Electro-Nucleonics Laboratories, Inc. | 1980-03-12 | Traditional | PDF ↗ |
| K800211 | IMMUNOGLOBULIN A REAGENT SYSTEM | Calbiochem-Behring Corp. | 1980-02-19 | Traditional | PDF ↗ |
| K791401 | LANCER L-INA ANTI-IGA | Sherwood Medical Co. | 1979-10-17 | Traditional | PDF ↗ |
| K790703 | ANTISERUM, HUMAN, IGA | Kent Laboratories, Inc. | 1979-04-12 | Traditional | PDF ↗ |
| K790479 | A-GENT IMMUNOGLOBULINE TEST SYSTEM | Abbott Laboratories | 1979-04-03 | Traditional | PDF ↗ |
| K772076 | RADIAL IMMUNODIFFUSION KIT-IMMUNOGLOB. | Gelman Instrument Co. | 1978-02-03 | Traditional | PDF ↗ |
| K772251 | IMMUNOGLOBULIN A NEPHEL. ASSAY | Kallestad Laboratories, Inc. | 1977-12-22 | Traditional | PDF ↗ |
| K771603 | IMMOCHEMISTRY SYSTEM | Beckman Instruments, Inc. | 1977-09-15 | Traditional | PDF ↗ |
| K770962 | GOAT ANTISERUM IGA NEPHELOMETRIC | Kallestad Laboratories, Inc. | 1977-06-24 | Traditional | PDF ↗ |
| K760146 | SERUM, IGA GOAT ANTI-HUMAN ACID | Oxford Laboratories, Inc. | 1976-07-20 | Traditional | PDF ↗ |
Product code CZP · Class II · Immunology. Data: openFDA.