FDA Product Code
FDA Product Code CFN — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Immunology
- 21 CFR Citation
- 866.5510
510(k) Clearances — 61 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K233663 | N Antisera to Human Immunoglobulins (IgG, IgA, and IgM) | Siemens Healthcare Diagnostics Products GmbH | 2023-12-13 | Special | PDF ↗ |
| K221114 | Immunoglobulin G (IgG) | Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd. | 2023-08-02 | Traditional | PDF ↗ |
| K192116 | Human IgA liquid reagent kit for Use on SPAPlus | The Binding Site Group , Ltd. | 2019-09-04 | Special | PDF ↗ |
| K191985 | Optilite IgA Kit | The Binding Site Group , Ltd. | 2019-08-19 | Special | PDF ↗ |
| K191635 | Optilite IgM Kit | The Binding Site Group , Ltd. | 2019-07-15 | Special | PDF ↗ |
| K191465 | Human IgM Kit for use on SPAPlus | The Binding Site Group , Ltd. | 2019-06-27 | Special | PDF ↗ |
| K190686 | Optilite IgM CSF Kit | The Binding Site Group , Ltd. | 2019-05-28 | Traditional | PDF ↗ |
| K183151 | Optilite IgA CSF Kit | The Binding Site Group , Ltd. | 2019-01-23 | Traditional | PDF ↗ |
| K162208 | DxC 700 AU Clinical Chemistry Analyzer, AU IgG Reagent | Beckman Coulter, Inc. | 2017-01-09 | Traditional | PDF ↗ |
| K150526 | Optilite IgG4 Kit | The Binding Site Group , Ltd. | 2015-05-30 | Traditional | PDF ↗ |
| K142735 | The Optilite IgG3 kit | The Binding Site Group , Ltd. | 2014-12-21 | Traditional | PDF ↗ |
| K130122 | BECKMAN COULTER IMMAGE IMMUNOCHEMISTRY SYSTEM LOW CONCENTRATION IMMUNOGLOBULIN, BECKMAN COULTER | Beckman Coulter, Inc. | 2014-01-07 | Traditional | PDF ↗ |
| K120901 | HUMAN IGA CSF KIT FOR USE ON SPAPLUS | The Binding Site Group , Ltd. | 2013-05-30 | Traditional | PDF ↗ |
| K120749 | HUMAN IGG CSF KIT | The Binding Site Group , Ltd. | 2013-05-17 | Traditional | PDF ↗ |
| K120750 | HUMAN IGM CSF KIT | The Binding Site Group , Ltd. | 2013-05-17 | Traditional | PDF ↗ |
| K113823 | HEVYLITE HUMAN IGM KAPPA AND HEVYLITE IGM LAMBDA KIT | The Binding Site Group , Ltd. | 2013-03-27 | Traditional | PDF ↗ |
| K103824 | HUMAN IGA LIQUID REAGENT KIT FOR USE ON SPA PLUS | The Binding Site | 2012-02-27 | Traditional | PDF ↗ |
| K100588 | HUMAN IGA2 KIT FOR USE ON THE SPAPLUS | The Binding Site Group , Ltd. | 2010-08-16 | Traditional | PDF ↗ |
| K082823 | HEVYLITE HUMAN IGA KAPPA AND IGA LAMBDA BN KITS | The Binding Site Group , Ltd. | 2010-03-01 | Traditional | PDF ↗ |
| K090920 | HUMAN IGG SUBCLASS LIQUID REAGENT KITS (FOR USE ON HITACHI 911/ 912/ 917 AND MODULAR P) | The Binding Site, Ltd. | 2009-12-30 | Traditional | PDF ↗ |
| K090594 | DIMENSION VISTA IMMUNOGLOBULIN A FLEX REAGENT CARTRIDGE (IGA), AND DIMENSION VISTA IMMUNOGLOBULIN M FLEX REAGENT CARTRID | Siemens Healthcare Diagnostics | 2009-04-29 | Traditional | PDF ↗ |
| K083445 | N ANTISERA TO HUMAN IMMUNOGLOBULINS (IGG, IGA AND IGM) AND N/T PROTEIN CONTROL LC | Siemens Healthcare Diagnostics | 2009-03-24 | Traditional | PDF ↗ |
| K082129 | HUMAN IGM LIQUID REAGENT KIT FOR USE ON THE SPAPLUS ANALYZER | The Binding Site, Ltd. | 2009-02-10 | Traditional | PDF ↗ |
| K081827 | HUMAN IGA LIQUID REAGENT KIT FOR USE ON SPAPLUS | The Binding Site, Ltd. | 2008-12-19 | Traditional | PDF ↗ |
| K081161 | DIMENSION VISTA SYSTEM IGG FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR, AND DIMENSION VISTA SYST | Dade Behring, Inc. | 2008-07-28 | Traditional | PDF ↗ |
| K073561 | DIMENSION VISTA SYSTEM IMMUNOGLOBULIN G FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR | Dade Behring, Inc. | 2008-02-26 | Traditional | PDF ↗ |
| K073489 | OLYMPUS IGA REAGENT | Olympus America, Inc. | 2008-02-11 | Traditional | PDF ↗ |
| K073487 | OLYMPUS IGM REAGENT | Olympus America, Inc. | 2008-02-11 | Traditional | PDF ↗ |
| K073490 | OLYMPUS IGG REAGENT | Olympus America, Inc. | 2008-02-11 | Traditional | PDF ↗ |
| K072889 | HUMAN IGG SUBCLASS LIQUID REAGENT KITS FOR USE ON THE SPAPLUS ANALYSER | The Binding Site, Ltd. | 2008-02-01 | Traditional | PDF ↗ |
| K061845 | DIMENSION VISTA IGM FLEX REAGENT CARTRIDGE AND PROTEIN 1 CALIBRATOR AND CONTROL L, M AND H | Dade Behring, Inc. | 2006-08-24 | Traditional | PDF ↗ |
| K061338 | DIMENSION VISTA IGA FLEX REAGENT CARTRIDGE ASSAY | Dade Behring, Inc. | 2006-07-06 | Traditional | PDF ↗ |
| K042735 | N ANTISERA TO HUMAN IMMUNOGLOBULINS (IGG, IGA AND IGM) | Dade Behring, Inc. | 2005-02-15 | Traditional | PDF ↗ |
| K042152 | BINDING SITE IGG SUBLCASS OLYMPUS KITS | The Binding Site | 2004-11-22 | Traditional | PDF ↗ |
| K042475 | VITROS CHEMISTRY PRODUCTS IGG, IGA AND IGM REAGENTS; VITROS CHEMISTRY PRODUCT CALIBRATOR KIT 20; VITROS CHEMISTRY PRODUC | Ortho-Clinical Diagnostics, Inc. | 2004-11-10 | Traditional | PDF ↗ |
| K032014 | N LATEX IGM | Dade Behring, Inc. | 2003-08-07 | Traditional | PDF ↗ |
| K022083 | HUMAN IGG SUBCLASS KIT FOR USE ON THE BECKMAN IMMAGE ANALYSER | The Binding Site, Ltd. | 2002-07-16 | Traditional | PDF ↗ |
| K012296 | HUMAN IGG SUBCLASS LIQUID REAGENT KITS, PRODUCT CODE LK001.T | The Binding Site, Ltd. | 2001-08-31 | Traditional | PDF ↗ |
| K012292 | HUMAN IGG SUBCLASS LIQUID REAGENT KITS, PRODUCT CODE LK001.TB | The Binding Site, Ltd. | 2001-08-31 | Traditional | PDF ↗ |
| K012295 | HUMAN IGG SUBCLASS LIQUID REAGENT KITS, PRODUCT CODE NK001.T | The Binding Site, Ltd. | 2001-08-20 | Traditional | PDF ↗ |
| K012291 | HUMAN IGG SUBCLASS LIQUID REAGENT KITS, PRODUCT CODE LK001.TA | The Binding Site, Ltd. | 2001-08-20 | Traditional | PDF ↗ |
| K000701 | HUMAN IGG SUBCLASS KIT USE WITH THE BECKMAN IMAGE ANALYZER | The Binding Site, Ltd. | 2000-04-27 | Traditional | PDF ↗ |
| K993547 | BECKMAN COULTER IMMAGE IMMUNOCHEMISTRY SYSTEM LOW CONCENTRATION IMMUNOGLOBULIN M (IGMLC) REAGENT, BECKMAN COULTER CEREB | Beckman Coulter, Inc. | 2000-02-01 | Traditional | PDF ↗ |
| K993549 | BECKMAN COULTER IMMAGE IMMUNOCHEMISTRY SYSTEM LOW CONCENTRATION IMMUNOGLOBULIN A (IGALC) REAGENT, BECKMAN COULTER CEREBR | Beckman Coulter, Inc. | 2000-02-01 | Traditional | PDF ↗ |
| K993924 | WAKO IGM II- HA, IMMUNOLOBULIN CALIBRATOR SET, IMMUNOLOBULIN STANDARD | Wako Chemicals USA, Inc. | 2000-01-14 | Traditional | PDF ↗ |
| K981784 | IGM MININEPH ANTISERUM | The Binding Site, Ltd. | 1999-12-21 | Traditional | PDF ↗ |
| K982100 | IGG AND IGG SUBCLASS NEPHELOMETRIC DIAGNOSTIC TEST KITS | The Binding Site, Ltd. | 1999-12-20 | Traditional | PDF ↗ |
| K981912 | HUMAN IGA SUBCLASS BNII COMBI KIT | The Binding Site, Ltd. | 1998-12-04 | Traditional | PDF ↗ |
| K982382 | COBAS INTEGRA REAGENT CASSETTES | Roche Diagnostic Systems, Inc. | 1998-09-28 | Traditional | PDF ↗ |
| K933970 | N-ASSAY TIA IGM | Crestat Diagnostics, Inc. | 1994-03-22 | Traditional | PDF ↗ |
| K933971 | N-ASSAY TIA IGA | Crestat Diagnostics, Inc. | 1994-03-22 | Traditional | PDF ↗ |
| K933973 | N-ASSAY TIA MULTI V-NL | Crestat Diagnostics, Inc. | 1994-01-28 | Traditional | PDF ↗ |
| K923070 | WAKO IGG-HA | Wako Chemicals USA, Inc. | 1992-08-20 | Traditional | PDF ↗ |
| K880356 | N PROTEIN STANDARD PLASMA (HUMAN) | Behring Diagnostics, Inc. | 1988-04-07 | Traditional | PDF ↗ |
| K871343 | QM2/QM300 BUFFER AND DILUENT PACK | Kallestad Diag, A Div. of Erbamont, Inc. | 1987-05-15 | Traditional | PDF ↗ |
| K864342 | MULTIPURPOSE IMMUNOCHEMISTRY SYSTEM LA-2000 LATEX | Eiken Chemical Co., Inc. | 1986-12-01 | Traditional | PDF ↗ |
| K860894 | BEHRING NEPHELOMETER SYSTEM | Behring Diagnostics, Inc. | 1986-04-15 | Traditional | PDF ↗ |
| K781656 | NEPHELRATE ANTISERUMS, IGG | Antibodies, Inc. | 1978-11-08 | Traditional | PDF ↗ |
| K781654 | NEPHELRATE ANTIPERUMS LGM | Antibodies, Inc. | 1978-11-08 | Traditional | PDF ↗ |
| K781655 | NEPHELRATE ANTISERUMS 1GA | Antibodies, Inc. | 1978-11-08 | Traditional | PDF ↗ |
| K771226 | LAS-R TEST PROGRAM | Hyland Therapeutic Div., Travenol Laboratories | 1977-07-21 | Traditional | PDF ↗ |
Product code CFN · Class II · Immunology. Data: openFDA.