Product code CFN
- Device name
- Method, Nephelometric, Immunoglobulins (G, A, M)
- Medical specialty
- Immunology
- Device class
- 2
- Regulation number
- 866.5510
- Review panel
- IM
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K233663 | N Antisera to Human Immunoglobulins (IgG, IgA, and IgM) | Siemens Healthcare Diagnostics Products GmbH | 2023-12-13 |
| K221114 | Immunoglobulin G (IgG) | Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd. | 2023-08-02 |
| K192116 | Human IgA liquid reagent kit for Use on SPAPlus | The Binding Site Group , Ltd. | 2019-09-04 |
| K191985 | Optilite IgA Kit | The Binding Site Group , Ltd. | 2019-08-19 |
| K191635 | Optilite IgM Kit | The Binding Site Group , Ltd. | 2019-07-15 |
| K191465 | Human IgM Kit for use on SPAPlus | The Binding Site Group , Ltd. | 2019-06-27 |
| K190686 | Optilite IgM CSF Kit | The Binding Site Group , Ltd. | 2019-05-28 |
| K183151 | Optilite IgA CSF Kit | The Binding Site Group , Ltd. | 2019-01-23 |
| K162208 | DxC 700 AU Clinical Chemistry Analyzer, AU IgG Reagent | Beckman Coulter, Inc. | 2017-01-09 |
| K150526 | Optilite IgG4 Kit | The Binding Site Group , Ltd. | 2015-05-30 |
| K142735 | The Optilite IgG3 kit | The Binding Site Group , Ltd. | 2014-12-21 |
| K130122 | BECKMAN COULTER IMMAGE IMMUNOCHEMISTRY SYSTEM LOW CONCENTRATION IMMUNOGLOBULIN, BECKMAN COULTER | Beckman Coulter, Inc. | 2014-01-07 |
| K120901 | HUMAN IGA CSF KIT FOR USE ON SPAPLUS | The Binding Site Group , Ltd. | 2013-05-30 |
| K120750 | HUMAN IGM CSF KIT | The Binding Site Group , Ltd. | 2013-05-17 |
| K120749 | HUMAN IGG CSF KIT | The Binding Site Group , Ltd. | 2013-05-17 |
| K113823 | HEVYLITE HUMAN IGM KAPPA AND HEVYLITE IGM LAMBDA KIT | The Binding Site Group , Ltd. | 2013-03-27 |
| K103824 | HUMAN IGA LIQUID REAGENT KIT FOR USE ON SPA PLUS | The Binding Site | 2012-02-27 |
| K100588 | HUMAN IGA2 KIT FOR USE ON THE SPAPLUS | The Binding Site Group , Ltd. | 2010-08-16 |
| K082823 | HEVYLITE HUMAN IGA KAPPA AND IGA LAMBDA BN KITS | The Binding Site Group , Ltd. | 2010-03-01 |
| K090920 | HUMAN IGG SUBCLASS LIQUID REAGENT KITS (FOR USE ON HITACHI 911/ 912/ 917 AND MODULAR P) | The Binding Site, Ltd. | 2009-12-30 |
| K090594 | DIMENSION VISTA IMMUNOGLOBULIN A FLEX REAGENT CARTRIDGE (IGA), AND DIMENSION VISTA IMMUNOGLOBULIN M FLEX REAGENT CARTRID | Siemens Healthcare Diagnostics | 2009-04-29 |
| K083445 | N ANTISERA TO HUMAN IMMUNOGLOBULINS (IGG, IGA AND IGM) AND N/T PROTEIN CONTROL LC | Siemens Healthcare Diagnostics | 2009-03-24 |
| K082129 | HUMAN IGM LIQUID REAGENT KIT FOR USE ON THE SPAPLUS ANALYZER | The Binding Site, Ltd. | 2009-02-10 |
| K081827 | HUMAN IGA LIQUID REAGENT KIT FOR USE ON SPAPLUS | The Binding Site, Ltd. | 2008-12-19 |
| K081161 | DIMENSION VISTA SYSTEM IGG FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR, AND DIMENSION VISTA SYST | Dade Behring, Inc. | 2008-07-28 |
| K073561 | DIMENSION VISTA SYSTEM IMMUNOGLOBULIN G FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR | Dade Behring, Inc. | 2008-02-26 |
| K073490 | OLYMPUS IGG REAGENT | Olympus America, Inc. | 2008-02-11 |
| K073489 | OLYMPUS IGA REAGENT | Olympus America, Inc. | 2008-02-11 |
| K073487 | OLYMPUS IGM REAGENT | Olympus America, Inc. | 2008-02-11 |
| K072889 | HUMAN IGG SUBCLASS LIQUID REAGENT KITS FOR USE ON THE SPAPLUS ANALYSER | The Binding Site, Ltd. | 2008-02-01 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 05051700021036 | Optilite® IgG3 Kit (x10) | THE BINDING SITE GROUP LIMITED | 2023-09-27 |
| 05051700021043 | Optilite® IgG4 Kit (x10) | THE BINDING SITE GROUP LIMITED | 2023-09-27 |
| 05051700020916 | Optilite® IgG Kit (x10) | THE BINDING SITE GROUP LIMITED | 2022-11-21 |
| 05051700020923 | Optilite® IgG1 Kit (x10) | THE BINDING SITE GROUP LIMITED | 2022-11-21 |
| 05051700020930 | Optilite® IgG2 Kit (x10) | THE BINDING SITE GROUP LIMITED | 2022-11-21 |
| 00630414285023 | N Latex IgM | Siemens Healthcare Diagnostics Products GmbH | 2020-05-29 |
| 05051700020183 | Optilite IgM CSF Kit | THE BINDING SITE GROUP LIMITED | 2020-01-31 |
| 05051700020190 | Optilite IgA CSF Kit | THE BINDING SITE GROUP LIMITED | 2019-06-21 |
| 05051700006163 | Human IgG3 Subclass Liquid Reagent Kit for use on the Siemens BN™II | THE BINDING SITE GROUP LIMITED | 2016-09-24 |
| 05051700006149 | Beckman Immage IgG3 Latex Kit | THE BINDING SITE GROUP LIMITED | 2016-09-24 |
| 05051700006132 | Human IgG3 Subclass Liquid Reagent Kit for use on Hitachi 911/912/917, Modular P | THE BINDING SITE GROUP LIMITED | 2016-09-24 |
| 05051700006118 | Olympus IgG3 Kit | THE BINDING SITE GROUP LIMITED | 2016-09-24 |
| 05051700006101 | Human IgG3 Subclass Liquid Reagent Kit for use on the Siemens BN™II - Bulk Kit | THE BINDING SITE GROUP LIMITED | 2016-09-24 |
| 05051700006095 | Human IgA Subclass Liquid Latex Reagent Kit for use on the Siemens BN™II | THE BINDING SITE GROUP LIMITED | 2016-09-24 |
| 05051700006088 | Human IgG Subclass Liquid Reagent Kit for use on the Siemens BN™II | THE BINDING SITE GROUP LIMITED | 2016-09-24 |
| 05051700006033 | Human IgG Subclass Liquid Reagent Kit for use on the Siemens BN™II - Bulk Kit | THE BINDING SITE GROUP LIMITED | 2016-09-24 |
| 15099590011598 | AU | Beckman Coulter, Inc. | 2016-09-24 |
| 15099590011581 | AU | Beckman Coulter, Inc. | 2016-09-24 |
| 15099590011574 | AU | Beckman Coulter, Inc. | 2016-09-24 |
| 04015630913725 | Immunoglobulin M | Roche Diagnostics GmbH | 2016-09-20 |
| 10758750006830 | VITROS | ORTHO-CLINICAL DIAGNOSTICS, INC. | 2016-08-26 |
| 10758750006823 | VITROS | ORTHO-CLINICAL DIAGNOSTICS, INC. | 2016-08-26 |
| 10758750006816 | VITROS | ORTHO-CLINICAL DIAGNOSTICS, INC. | 2016-08-26 |
| 15099590221218 | IMMAGE | Beckman Coulter, Inc. | 2016-08-24 |
| 15099590221225 | IMMAGE | Beckman Coulter, Inc. | 2016-08-24 |
| 15099590223885 | IMMAGE | Beckman Coulter, Inc. | 2016-08-24 |
| 15099590226985 | IMMAGE | Beckman Coulter, Inc. | 2016-08-24 |
| 15099590227029 | IMMAGE | Beckman Coulter, Inc. | 2016-08-24 |
| 15099590230470 | IMMAGE | Beckman Coulter, Inc. | 2016-08-24 |
| 15099590221195 | IMMAGE | Beckman Coulter, Inc. | 2016-08-24 |