PCN
3 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Immunoglobulin G Kappa Heavy And Light Chain Combined
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5510
- Medical specialty
- Immunology
- Flags
- Third-party review eligible
- FDA definition
- Intended for the in-vitro quantification of IgG kappa concentration in human serum.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Optilite Hevylite IgG Kappa Kit, Optilite Hevylite IgG Lambda Kit (K172613) | The Binding Site Group , Ltd. | 2018-02-15 |
| Hevylite Human IgG Kappa Kit for use on the SPAPLUS, Hevylite Human IgG Lambda Kit for use on the SPAPLUS (K161854) | The Binding Site Group , Ltd. | 2016-10-04 |
| HEVYLITE HUMAN IGG KAPPA KIT AND HEVYLITE HUMAN IGG LAMBDA KIT (K132555) | The Binding Site | 2013-12-20 |
Track PCN automatically
Every clearance here is in the API, with alerts when new ones post.