Product code PCN
- Device name
- Immunoglobulin G Kappa Heavy And Light Chain Combined
- 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
- Definition
- Intended for the in-vitro quantification of IgG kappa concentration in human serum.
- Source
- FDA openFDA device classification dataset
Related 510(k) Records
| 510(k) | Device | Applicant | Decision date |
|---|
| K172613 | Optilite Hevylite IgG Kappa Kit, Optilite Hevylite IgG Lambda Kit | The Binding Site Group , Ltd. | 2018-02-15 |
| K161854 | Hevylite Human IgG Kappa Kit for use on the SPAPLUS, Hevylite Human IgG Lambda Kit for use on the SPAPLUS | The Binding Site Group , Ltd. | 2016-10-04 |
| K132555 | HEVYLITE HUMAN IGG KAPPA KIT AND HEVYLITE HUMAN IGG LAMBDA KIT | The Binding Site | 2013-12-20 |
Related GUDID Devices
| Primary DI | Brand | Company | Published |
|---|
| 05051700020114 | Optilite Hevylite IgG Kappa Kit | THE BINDING SITE GROUP LIMITED | 2018-04-12 |
| 05051700019378 | Hevylite Human IgG Kappa Kit for use on the SPAPLU | THE BINDING SITE GROUP LIMITED | 2017-07-25 |
| 05051700016971 | Hevylite IgG Kappa Kit for Siemens BNII | THE BINDING SITE GROUP LIMITED | 2016-09-24 |