Panels › Immunology › Product code PCN · Class 2
Immunoglobulin G Kappa Heavy And Light Chain Combined
Regulation 866.5510
0510(k)s in 12 months (3 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in PCN
| Company | 510(k)s | Recalls |
|---|---|---|
| The Binding Site Group , Ltd. | 2 | 0 |
| The Binding Site | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 15, 2018 | K172613 | Optilite Hevylite IgG Kappa Kit, Optilite Hevylite IgG Lambda Kit The Binding Site Group , Ltd., GB | PCN |
| Oct 4, 2016 | 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., GB | PCN |
| Dec 20, 2013 | K132555 | HEVYLITE HUMAN IGG KAPPA KIT AND HEVYLITE HUMAN IGG LAMBDA KIT The Binding Site, GB | PCN |
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